Intelligent wireless communications for continuous analyte monitoring

ABSTRACT

Various embodiments relate generally to continuous monitoring of analyte values received from an analyte sensor system. In some example embodiments, there is provided a method that includes receiving sensor information, calculating and storing estimated analyte measurement values based upon the received sensor information. The method also includes determining one or more communication conditions, and instructing a transceiver to advertise to a first display device in accordance with one or more communication variables based upon the one or more communication conditions. The method then transmits the estimated analyte measurement values to the at least first display device. Related systems, methods, and articles of manufacture are also described.

INCORPORATION BY REFERENCE TO RELATED APPLICATION

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application is a continuation of U.S. application Ser.No. 15/384,944, filed on Dec. 20, 2016, which claims the benefit of U.S.Provisional Appl. No. 62/271,880, filed on Dec. 28, 2015. Theaforementioned applications are incorporated by reference herein intheir entirety, and are hereby expressly made a part of thisspecification.

FIELD

Various embodiments relate generally to continuous monitoring of analytevalues received from an analyte sensor system.

BACKGROUND

Diabetes mellitus is a disorder in which the pancreas cannot createsufficient insulin (Type I or insulin dependent) and/or in which insulinis not effective (Type 2 or non-insulin dependent). In the diabeticstate, the victim suffers from high blood sugar, which causes an arrayof physiological derangements (kidney failure, skin ulcers, or bleedinginto the vitreous of the eye) associated with the deterioration of smallblood vessels. A hypoglycemic reaction (low blood sugar) may be inducedby an inadvertent overdose of insulin, or after a normal dose of insulinor glucose-lowering agent accompanied by extraordinary exercise orinsufficient food intake.

Conventionally, a diabetic person carries a self-monitoring bloodglucose (SMBG) monitor, which typically requires uncomfortable fingerpricking methods. Due to the lack of comfort and convenience, a diabeticperson will normally only measure his or her glucose level two to fourtimes per day. Unfortunately, these time intervals are spread so farapart that the diabetic person will likely find out too late, sometimesincurring dangerous side effects, of a hyperglycemic or hypoglycemiccondition. In fact, it is not only unlikely that a diabetic person willtake a timely SMBG value, but it is also unlikely that the diabetic willknow if his or her blood glucose value is going up (higher) or down(lower) utilizing conventional monitoring systems and methods.

Consequently, a variety of non-invasive, transdermal (e.g.,transcutaneous) and/or implantable electrochemical sensors are beingdeveloped for continuously detecting and/or quantifying blood glucosevalues. These devices generally transmit raw or minimally processed datafor subsequent analysis at a remote device, which can include a display.

SUMMARY

Details of one or more implementations of the subject matter describedin this specification are set forth in the accompanying drawings and thedescription below. Other features, aspects, and advantages will becomeapparent from the description, the drawings, and the claims. Note thatthe relative dimensions of the following figures may not be drawn toscale. In some aspects of the disclosed technology, acomputer-implemented method includes receiving sensor information;calculating and storing estimated analyte measurement values based uponthe received sensor information; determining one or more communicationconditions; instructing a transceiver to advertise to at least a firstdisplay device in accordance with one or more communication variablesbased upon the one or more communication conditions; and transmittingthe estimated analyte measurement values to the at least first displaydevice. In some implementations, the computer-implemented method furtherincludes determining the one or more communication conditions comprisesdetermining at least one of the following: a time associated with thecommunication conditions; historical communication conditions; anexistence of an alarm condition; a condition of the continuous glucosemonitoring sensor; a condition of a user of the continuous glucosemonitoring sensor; and whitelist conditions. In some implementations,the one or more communication variables includes at least one of anadvertising duration parameter and an advertising interval parameteraccording to which advertising beacons are transmitted to the firstdisplay device, and wherein the at least one of the advertising durationand advertising interval parameters are adjusted to the first displaydevice. In some implementations, the first display device includes oneof a last-connected display device populating the whitelist, a preferreddisplay device populating the whitelist, and a display device configuredto advertise to at least a second display device. In someimplementations, the alarm condition comprises a determination that thecondition of the user is approaching or experiencing a medicallycritical state. In some implementations, the one or more communicationvariables are optimized for establishing a wireless communicationsession with the first display device. In some implementations, theoptimization of the one or more communication variables includes atleast one of increasing a default advertising duration parameter anddecreasing a default advertising interval parameter. In some examples,the one or more communication variables are optimized for establishing awireless communication session with the first display device upon adetermination that the estimated analyte measurement values areindicative of a trend towards a medically critical state. In someimplementations, the one or more communication variables are adjustedfor delaying establishment of a wireless communication session with thefirst display device upon a determination that the estimated analytemeasurement values are indicative of a trend towards a medicallynon-critical state.

In some aspects of the disclosed technology, an apparatus includessignal conditioning circuitry communicatively connected to a continuousanalyte sensor for receiving sensor information from the continuousanalyte sensor indicative of analyte levels of a host to which thecontinuous analyte sensor is operatively attached; a processor, whereinupon receiving the sensor information from the signal conditioningcircuitry, instructs a radio to perform the following: transmit aplurality of advertising beacons to a first display device in accordancewith one or more communication variables based upon one or morecommunication conditions determined by the apparatus; and upon the firstdisplay device responding to one of the plurality of advertisingbeacons, establish a wireless communication session with the firstdisplay device and transmit the sensor information or analyte valuesderived from the sensor information to the at least first displaydevice. In some implementations, the one or more communication variablesincludes at least one of: a transmission frequency variable indicating afrequency with which the sensor information or the analyte values aretransmitted to the first display device; a transmission protocolindicating a wireless communication protocol to be utilized in thetransmission of the sensor information or the analyte values to thefirst display device; a communications type variable indicating aone-way communication or a two-way communication with the first displayduring the transmission of the sensor information or the analyte valuesto the first display device; and a transmission occurrence variableindicating whether the transmission of the sensor information or theanalyte values to the first display device are to occur in an on-demandor automatic manner. In some implementations, the one or morecommunication variables further includes: a data packet format typevariable to be utilized for the transmission of the plurality ofadvertising beacons; an advertising duration variable indicative of aduration for which the first display device is to be advertised to; anadvertising interval variable indicative of an amount of time betweenthe transmission of each of the plurality of advertising beacons; and apower variable indicative of power to be used by the radio for thetransmission of the advertising beacons. In some implementations, theone or more communication variables further includes a display devicetype variable indicating a type of at least one of the first displaydevice and additional display devices to which the sensor information oranalyte values are to be sent; a display device number indicating anumber of display devices available to receive the sensor information oranalyte values; an order variable indicating a connection order ofdisplay devices previously having established a wireless communicationsession with the radio; a role variable indicating whether at least oneof the first display device and the additional display devices are atleast one of a primary display device, a secondary display device, apreferred display device, a scan-only display device, an advertisingdisplay device, and a sensor information or analyte values forwardingdisplay device; and a broadcast mode variable indicating one-way ortwo-way broadcasting to be used in conjunction with at least one of thefirst display device and the additional display devices if the at leastone of the first display device and the additional display devicescomprise an advertising display device or a sensor information oranalyte values forwarding display device.

In some aspects of the disclosed technology, a computer-implementedmethod, includes calculating and storing estimated glucose value databased upon glucose measurements obtained by a continuous glucosemonitoring sensor; determining one or more communication conditions; andadvertising to one or more display devices in a manner based on the oneor more communication conditions. In some implementations, thedetermination of the one or more communication conditions includesanalyzing historical estimated glucose value data. In someimplementations, the analysis of the historical estimated glucose valuedata results in an observed trend. In some implementations, thedetermination of the one or more communication conditions furtherincludes determining whether an alarm condition exists based on theobserved trend. In some implementations, the advertising to the one ormore displays includes incorporating the estimated glucose value data inadvertising beacons upon a determination that no alarm condition exists.In some implementations, the estimated glucose value data isincorporated in the advertising beacons in an encrypted format. In someimplementations, the advertising to the one or more displays includestransmitting advertising beacons to the one or more display devices upona determination that an alarm condition exists. In some examples, thecomputer-implemented method further includes establishing wirelesscommunication sessions during which the estimated glucose value data istransmitted to the one or more display devices upon the one or moredisplay devices responding to their respective advertising beacons.

In some aspects of the disclosed technology, an apparatus includes: acontinuous analyte sensor adapted to obtain raw analyte data; aprocessor and a memory unit having computer code configured to cause theprocessor to: calculate and store analyte value data derived from theraw analyte data; determine one or more communication conditions; and aradio adapted to advertise to one or more display devices in a mannerbased on the one or more communication conditions.

In some aspects of the disclosed technology, an apparatus includes amemory; and a processor, the memory having computer code configured tocause the processor to: receive estimated glucose value data; and basedupon observed communication conditions and communication variablesadapted based on the observed communication conditions, transmit theestimated glucose value data to one or more display devices.

Any of the features of aspects specified herein are applicable to allother aspects and embodiments identified herein. Moreover, any of thefeatures of an aspect is independently combinable, partly or wholly withother aspects described herein in any way, e.g., one, two, or three ormore aspects may be combinable in whole or in part. Further, any of thefeatures of an aspect may be made optional to other aspects. Any aspectof a method can be performed by a system or apparatus of another aspect,and any aspect or of a system can be configured to perform a method ofanother aspect.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are described in detail with reference to theaccompanying figures. The drawings are provided for purposes ofillustration only and merely depict typical or example embodiments.These drawings are provided to facilitate the reader's understanding ofthe systems and methods described herein, and shall not be consideredlimiting of the breadth, scope, or applicability of the variousembodiments.

FIG. 1 is a diagram illustrating certain embodiments of an examplecontinuous analyte sensor system communicating with at least one displaydevice in accordance with various technologies described in the presentdisclosure.

FIG. 2A is a perspective view of an example sensor electronics module ofthe example continuous analyte sensor system of FIG. 1.

FIG. 2B is a side view of the example sensor electronics module of FIG.2A.

FIG. 3 is a block diagram illustrating elements of an example continuousanalyte monitoring system and display devices in accordance with variousembodiments described in the present disclosure.

FIG. 4 is an example advertising/connection sequence in accordancevarious embodiments described in the present disclosure.

FIG. 5 is a block diagram illustrating various elements involved in thetransmission of data from an example continuous analyte monitoringsystem in accordance with various embodiments described in the presentdisclosure.

FIG. 6 is an example transmitter processing/command sequence inaccordance with various embodiments described in the present disclosure.

FIG. 7A is an example advertising profile in accordance with variousembodiments described in the present disclosure.

FIG. 7B is an example connection profile in accordance with variousembodiments described in the present disclosure.

FIG. 7C is an illustration of an example operating interval inaccordance with various embodiments described in the present disclosure.

FIGS. 8A-8H are flow charts illustrating example processes performed foradapting communications in accordance with communication conditions andcommunication variables in accordance with various embodiments of thepresent disclosure.

FIG. 9 is a diagram illustrating certain alternative examples of acontinuous analyte sensor system communicating with at least one displaydevice in accordance with various technologies described in the presentdisclosure.

FIG. 10 is a block diagram of an example computing module that may beused to implement various features of embodiments described in thepresent disclosure.

DETAILED DESCRIPTION

The following description illustrates some example embodiments of thedisclosed technology or technologies in detail. Those of skill in theart will recognize that there are numerous variations and modificationsof the disclosed embodiments encompassed by its scope. Accordingly, thedescription of a certain example embodiments should not be deemed tolimit the scope of the present disclosure.

Overview

As alluded to previously, continuous monitoring of blood glucose values,one example of an analyte (discussed in greater detail below) canimprove upon conventional monitoring systems and methods by improvingcomfort and convenience, as well as lessening the chance that a person'sdeteriorating or medically critical condition goes unnoticed. Thus,various embodiments described herein are directed to systems and methodsof continuous analyte monitoring and the optimization ofcommunications/initiating communications for the transmittal and receiptof continually monitored analyte data.

In some embodiments, a system is provided for continuous measurement ofan analyte in a host that can include: a continuous analyte sensorconfigured to continuously measure a concentration of the analyte in thehost; and a sensor electronics module physically connected to thecontinuous analyte sensor to receive the analyte concentrationmeasurements and communicate them to display devices. In particular, thesensor electronics module includes electronics configured to process adata stream associated with an analyte concentration measured by thecontinuous analyte sensor in order to generate sensor information thatincludes raw sensor data, transformed sensor data, and/or any othersensor data or data derived therefrom, e.g., predictive or trend data.The sensor electronics module may further be configured to generatesensor information that is customized for respective display devices,such that different display devices may receive different sensorinformation for presentation to the host, a host care taker, etc.

Communications between the sensor electronics module and one or moredisplay devices can be controlled via an advertising and connectionprotocol indicating, for example, how often and/or how long the sensorelectronics module advertises to a display device, the order in whichthe sensor electronics module advertised to a display device, etc. Thesensor electronics module may comprise a communications unit operativein accordance with the advertising and connection protocol, such as aradio transceiver, that effectuates such communications between thesensor electronics module and the one or more display devices. Thecontrol effectuated by the advertising and connection protocol can beachieved by varying or adjusting variables or parameters that can impactcommunications in accordance with one or more communication conditionsthat can be accounted for.

As can be appreciated, the nature of continual analyte measurement, aswell as a desired form factor for the sensor electronics module would bewell-served by a power efficient design. Thus, the initiation ofcommunication between the sensor electronics module and display devices,as well as communications themselves are optimized in accordance withvarious embodiments so as to maximize battery life in the sensorelectronics module. In addition to power savings, this optimization canimprove connection reliability between the sensor electronics module anddisplay devices, as well as reduce connection delays and/or delaysassociated with presenting sensor information to the host.

The term “analyte” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a substance or chemicalconstituent in a biological fluid (for example, blood, interstitialfluid, cerebral spinal fluid, lymph fluid or urine) that can beanalyzed. Analytes can include naturally occurring substances,artificial substances, metabolites, and/or reaction products. In someembodiments, the analyte for measurement by the sensor heads, devices,and methods is analyte. However, other analytes are contemplated aswell, including but not limited to acarboxyprothrombin; acylcarnitine;adenine phosphoribosyl transferase; adenosine deaminase; albumin;alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle),histidine/urocanic acid, homocysteine, phenylalanine/tyrosine,tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers;arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactiveprotein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholicacid; chloroquine; cholesterol; cholinesterase; conjugated 1-ßhydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MMisoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine;dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcoholdehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Beckermuscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A,hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F,D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1,Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax,sexual differentiation, 21-deoxycortisol); desbutylhalofantrine;dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocytearginase; erythrocyte protoporphyrin; esterase D; fattyacids/acylglycines; free ß-human chorionic gonadotropin; freeerythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine(FT3); fumarylacetoacetase; galactose/gal-1-phosphate;galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphatedehydrogenase; glutathione; glutathione perioxidase; glycocholic acid;glycosylated hemoglobin; halofantrine; hemoglobin variants;hexosaminidase A; human erythrocyte carbonic anhydrase I;17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase;immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, ß);lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin;phytanic/pristanic acid; progesterone; prolactin; prolidase; purinenucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);selenium; serum pancreatic lipase; sissomicin; somatomedin C; specificantibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody,arbovirus, Aujeszky's disease virus, dengue virus, Dracunculusmedinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmaniadonovani, leptospira, measles/mumps/rubella, Mycobacterium leprae,Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenzavirus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa,respiratory syncytial virus, rickettsia (scrub typhus), Schistosomamansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosomacruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellowfever virus); specific antigens (hepatitis B virus, HIV-1);succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine(T4); thyroxine-binding globulin; trace elements; transferring;UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A;white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat,vitamins, and hormones naturally occurring in blood or interstitialfluids can also constitute analytes in certain embodiments. The analytecan be naturally present in the biological fluid, for example, ametabolic product, a hormone, an antigen, an antibody, and the like.Alternatively, the analyte can be introduced into the body, for example,a contrast agent for imaging, a radioisotope, a chemical agent, afluorocarbon-based synthetic blood, or a drug or pharmaceuticalcomposition, including but not limited to insulin; ethanol; cannabis(marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide,amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine(crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin,Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine);depressants (barbiturates, methaqualone, tranquilizers such as Valium,Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens(phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics(heroin, codeine, morphine, opium, meperidine, Percocet, Percodan,Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogsof fentanyl, meperidine, amphetamines, methamphetamines, andphencyclidine, for example, Ecstasy); anabolic steroids; and nicotine.The metabolic products of drugs and pharmaceutical compositions are alsocontemplated analytes. Analytes such as neurochemicals and otherchemicals generated within the body can also be analyzed, such as, forexample, ascorbic acid, uric acid, dopamine, noradrenaline,3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC),Homovanillic acid (HVA), 5-Hydroxytryptamine (5HT), and5-Hydroxyindoleacetic acid (FHIAA).

Display Devices

In some embodiments, the sensor electronics module may be configured tosearch for and/or attempt to wirelessly communicate with a displaydevice, such as one from a list of display devices (also referred to asa whitelist). This list of display devices reflects those displaydevices that have successfully been paired or bonded with the sensorelectronics module. For example, a display device may respond to anadvertising signal transmitted by the sensor electronics module. Uponreceiving this response, the list may be updated with an identifierindicative of the display device. In some embodiments, a display devicemay be removed from the list after some predetermined time ofinactivity, e.g., no communications between the sensor electronicsmodule and the display device. In some embodiments, another list(referred to as a bonding list) may be utilized to maintain a listing ofdisplay devices that were previously paired to or bonded with the sensorelectronics module. Re-pairing a display device to the sensorelectronics module can be avoided when utilizing a bonding list. Forexample, if a display device is removed from the whitelist, e.g., due tosome predetermined amount of inactivity, the identifier of that displaydevice may be stored in the bonding list. In other embodiments, uponpairing or bonding/inclusion in the whitelist, the display deviceidentifier may also be stored in the bonding list. In this way, thebonding list can be accessed upon the sensor electronics modulereceiving a response to an advertising signal from a display device tocheck whether or not the display device was previously bonded to thesensor electronics module. If so, a data connection can be establishedwithout engaging in authentication (discussed below with respect to FIG.4).

In some embodiments, the search for and/or attempted wirelesscommunication can occur in a predetermined and/or programmable order(e.g., grading and/or escalating). For example, if an attempt atcommunicating with and/or alarming a first display device fails, thisfailure triggers an attempt to communicate with and/or alarm a seconddisplay device, and so on. It should be noted that the sensorelectronics module is not necessarily tied to a single display device.Rather the sensor electronics module is configured to communicate with aplurality of different display devices directly, systematically,simultaneously (e.g., via broadcasting), regularly, periodically,randomly, on-demand, in response to a query, based on alerts or alarms,and/or the like.

The sensor information may comprise transformed sensor information thatdoes not require processing by the display device prior to display ofthe sensor information. However, some display devices may comprisesoftware including display instructions (software programming comprisinginstructions configured to display the sensor information and optionallyquery the sensor electronics module to obtain the sensor information)configured to enable display of the sensor information thereon. In someembodiments, the display device is programmed with the displayinstructions at the manufacturer and can include security and/orauthentication to avoid plagiarism of the display device. In someembodiments, a display device is configured to display the sensorinformation via a downloadable program (for example, a downloadable JavaScript via the internet), such that any display device that supportsdownloading of a program (for example, any display device that supportsJava applets) can be configured to display displayable sensorinformation (e.g., mobile phones, tablets, PDAs, PCs and the like).

In some embodiments, certain display devices may be in direct wirelesscommunication with the sensor electronics module, although intermediatenetwork hardware, firmware, and/or software can be included within thedirect wireless communication. In some embodiments, a repeater (e.g., aBluetooth repeater) can be used to re-transmit the transmitted sensorinformation to a location farther away than the immediate range of thetelemetry module of the sensor electronics module. In some embodiments,a receiver (e.g., Bluetooth receiver) can be used to re-transmit thetransmitted sensor information to a display device, e.g., a TV screen,possibly in a different format, such as in a text message. In certainembodiments, the sensor electronics module transmits sensor informationto one or more display devices, where the sensor information transmittedfrom the sensor electronics module is received by the display devicewithout intermediate processing of the sensor information.

In some embodiments, one or more display devices are configured to querythe sensor electronics module for sensor information, where the displaydevice requests sensor information from the sensor electronics module inan “on-demand” fashion, for example, in response to a query. In someembodiments, the sensor electronics module is configured for periodic,systematic, regular, irregular or aperiodic transmission of sensorinformation to one or more display devices (for example, every 1, 2, 5,or 10 minutes or more). In some embodiments, the sensor electronicsmodule is configured to transmit data packages associated with atriggered alert (e.g., triggered by one or more alert conditions).However, any combination of the above-described statuses of datatransmission can be implemented with any combination of a paired sensorelectronics module and display device(s). For example, one or moredisplay devices can be configured for querying a sensor electronicsmodule database and for receiving alarm information triggered by one ormore alarm conditions being met. Additionally, the sensor electronicsmodule can be configured to transmit sensor information to one or moredisplay devices (the same or different display devices as described inthe previous example), where the display devices function differentlywith regard to how they obtain sensor information.

In some embodiments, as described in more detail below, a display deviceis configured to query data storage memory in the sensor electronicsmodule for certain types of data content, including direct queries intoa database in the sensor electronics module's memory and/or requests forconfigured or configurable packages of data content therefrom; namely,the data stored in the sensor electronics module is configurable,queryable, predetermined, and/or pre-packaged, based on the displaydevice with which the sensor electronics module is communicating. Insome additional or alternative embodiments, the sensor electronicsmodule generates the sensor information based on its knowledge of whichdisplay device is to receive a particular transmission. Additionally,some display devices are capable of obtaining calibration informationand wirelessly transmitting the calibration information to the sensorelectronics module, such as through manual entry of the calibrationinformation, automatic delivery of the calibration information, and/oran integral reference analyte monitor incorporated into the displaydevice. U.S. Patent Publication Nos. 2006/0222566, 2007/0203966,2007/0208245, and 2005/0154271, all of which are incorporated herein byreference in their entirety, describe systems and methods for providingan integral reference analyte monitor incorporated into a display deviceand/or other calibration methods that can be implemented withembodiments disclosed herein.

In general, a plurality of display devices (e.g., a custom analytemonitoring device, a mobile phone, a tablet, a smart watch, a referenceanalyte monitor, a medicament delivery device, a medical device and apersonal computer) may be configured to wirelessly communicate with thesensor electronics module. The one or more display devices can beconfigured to display at least some of the sensor information wirelesslycommunicated by the sensor electronics module. The sensor informationmay include, for example, sensor data, such as raw data and/ortransformed sensor data, such as analyte concentration values, rate ofchange information, trend information, alert information, sensordiagnostic information, calibration information, non-visual informationsuch as temperature readings, sound, etc.

Example Configurations

FIG. 1 is a diagram depicting an example continuous analyte monitoringsystem 100 including an analyte sensor system 104 operatively connectedto a host 102 and a plurality of display devices 120 according tocertain aspects of the present disclosure. For ease of reference,reference number 120 may be used to refer to the plurality of displaydevices together as a group, whereas respective alphanumeric referencenumbers 120 a, 120 b, 120 c, 120 d, and/or 120 e may be used to refer tospecific display devices. It should be noted that display device 120 ealternatively or in addition to being a display device, may be amedicament delivery device that can act cooperatively with the analytesensor system 104 to deliver medicaments to host 102. The analyte sensorsystem 104 may include a sensor electronics module 106 and a continuousanalyte sensor 108 associated with the sensor electronics module 106.The sensor electronics module 106 may be in direct wirelesscommunication with one or more of the plurality of the display devices120 via wireless communications signals. As will be discussed in greaterdetail below, display devices 120 may also communicate amongst eachother and/or through each other to analyte sensor system 104. For easeof reference, wireless communications signals from analyte sensor system104 to display devices 120 can be referred to as “uplink” signals 112.Wireless communications signals from, e.g., display devices 120 toanalyte sensor system 104 can be referred to as “downlink” signals 114.Wireless communication signals between two or more of display devices120 may be referred to as “crosslink” signals 116. Additionally,wireless communication signals may include data transmitted by one ormore of display devices 120 a-d via “long-range” uplink signals 136(e.g., cellular signals) to one or more remote servers 140 or networkentities, such as cloud-based servers or databases, and receivelong-range downlink signals 138 transmitted by remote servers 140.

The sensor electronics module 106 includes sensor electronics that areconfigured to process sensor information and generate transformed sensorinformation. In certain embodiments, the sensor electronics module 106includes electronic circuitry associated with measuring and processingdata from continuous analyte sensor 108, including prospectivealgorithms associated with processing and calibration of the continuousanalyte sensor data. The sensor electronics module 106 can be integralwith (non-releasably attached to) or releasably attachable to thecontinuous analyte sensor 108 achieving a physical connectiontherebetween. The sensor electronics module 106 may include hardware,firmware, and/or software that enables analyte level measurement. Forexample, the sensor electronics module 106 can include a potentiostat, apower source for providing power to continuous analyte sensor 108, othercomponents useful for signal processing and data storage, and atelemetry module for transmitting data from itself to one or moredisplay devices 120. Electronics can be affixed to a printed circuitboard (PCB), or the like, and can take a variety of forms. For example,the electronics can take the form of an integrated circuit (IC), such asan Application-Specific Integrated Circuit (ASIC), a microcontroller,and/or a processor. Examples of systems and methods for processingsensor analyte data are described in more detail herein and in U.S. Pat.Nos. 7,310,544 and 6,931,327 and U.S. Patent Publication Nos.2005/0043598, 2007/0032706, 2007/0016381, 2008/0033254, 2005/0203360,2005/0154271, 2005/0192557, 2006/0222566, 2007/0203966 and 2007/0208245,all of which are incorporated herein by reference in their entirety forall purposes.

Referring again to FIG. 1, display devices 120 are configured fordisplaying, alarming, and/or basing medicament delivery on the sensorinformation that has been transmitted by the sensor electronics module106 (e.g., in a customized data package that is transmitted to one ormore of display devices 120 based on their respective preferences). Eachof the display devices 120 can include a display such as a touchscreendisplay for displaying sensor information to a user (most often host 102or a care taker/medical professional) and/or receiving inputs from theuser. In some embodiments, the display devices 120 may include othertypes of user interfaces such as a voice user interface instead of or inaddition to a touchscreen display for communicating sensor informationto the user of the display device 120 and/or receiving user inputs. Insome embodiments, one, some or all of the display devices 120 areconfigured to display or otherwise communicate the sensor information asit is communicated from the sensor electronics module 106 (e.g., in adata package that is transmitted to respective display devices 120),without any additional prospective processing required for calibrationand real-time display of the sensor information.

In the embodiment of FIG. 1, one of the plurality of display devices 120may be a custom display device 120 a specially designed for displayingcertain types of displayable sensor information associated with analytevalues received from the sensor electronics module 106 (e.g., anumerical value and an arrow, in some embodiments). In some embodiments,one of the plurality of display devices 120 may be a handheld device 120c, such as a mobile phone based on the Android or iOS operating system,a palm-top computer and the like, where handheld device 120 c may have arelatively larger display and be configured to display a graphicalrepresentation of the continuous sensor data (e.g., including currentand historic data). Other display devices can include other hand-helddevices, such as a tablet 120 d, a smart watch 120 b, a medicamentdelivery device 120 e, a blood glucose meter, and/or a desktop or laptopcomputer.

As alluded to above, because the different display devices 120 providedifferent user interfaces, content of the data packages (e.g., amount,format, and/or type of data to be displayed, alarms, and the like) canbe customized (e.g., programmed differently by the manufacture and/or byan end user) for each particular display device and/or display devicetype. Accordingly, in the embodiment of FIG. 1, one or more of displaydevices 120 can be in direct or indirect wireless communication with thesensor electronics module 106 to enable a plurality of different typesand/or levels of display and/or functionality associated with the sensorinformation, which is described in more detail elsewhere herein.

Continuous Analyte Sensor

Continuous analyte sensor 108 of FIG. 1 may be, for example asubcutaneous, transdermal (e.g., transcutaneous), or intravasculardevice. In some embodiments, continuous analyte sensor 108 can analyze aplurality of intermittent blood samples, although continuous analytesensor 108 can be configured to use any method of analyte-measurement,including enzymatic, chemical, physical, electrochemical,spectrophotometric, polarimetric, calorimetric, iontophoretic,radiometric, immunochemical, and the like.

Continuous analyte sensor 108 can use any known method, includinginvasive, minimally invasive, and non-invasive sensing techniques (e.g.,fluorescent monitoring), to provide a data stream indicative of theconcentration of a measured analyte in host 102. In some embodiments,this data stream is typically a raw data signal, which is converted intoa calibrated and/or filtered data stream that is used to provide auseful value of the measured analyte to a user, such as host 102 or acaretaker (e.g., a parent, a relative, a guardian, a teacher, a doctor,a nurse, or any other individual that has an interest in the well-beingof host 102). It should be understood that the devices and methodsdescribed herein can be applied to any device capable of detecting aconcentration of an analyte and providing an output signal thatrepresents the concentration of the analyte.

In some embodiments, continuous analyte sensor 108 may be capable ofmeasuring a concentration of glucose in host 102, one of which isdescribed below as utilizing an implantable continuous glucose sensor.For example, continuous analyte sensor 108 may be an implantable glucosesensor, such as described with reference to U.S. Pat. No. 6,001,067 andU.S. Patent Publication No. US-2005-0027463-A1. In another embodiment,continuous analyte sensor 108 may be a transcutaneous glucose sensor,such as described with reference to U.S. Patent Publication No.US-2006-0020187-A1. In still other embodiments, continuous analytesensor 108 may be configured to be implanted in a host vessel orextracorporeally, such as is described in U.S. Patent Publication No.US-2007-0027385-A1, co-pending U.S. Patent Publication No.US-2008-0119703-A1 filed Oct. 4, 2006, co-pending U.S. PatentPublication No. US-2008-0108942-A1 filed on Mar. 26, 2007, andco-pending U.S. Patent Application No. US-2007-0197890-A1 filed on Feb.14, 2007. In one alternative embodiment, continuous analyte sensor 108comprises a transcutaneous sensor such as described in U.S. Pat. No.6,565,509 to Say et al., for example. In another alternative embodiment,continuous analyte sensor 108 comprises a subcutaneous sensor such asdescribed with reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al.or U.S. Pat. No. 6,484,046 to Say et al., for example. In anotheralternative embodiment, continuous analyte sensor 108 comprises arefillable subcutaneous sensor such as described with reference to U.S.Pat. No. 6,512,939 to Colvin et al., for example. In another alternativeembodiment, continuous analyte sensor 108 comprises an intravascularsensor such as described with reference to U.S. Pat. No. 6,477,395 toSchulman et al., for example. In another alternative embodiment,continuous analyte sensor 108 comprises an intravascular sensor such asdescribed with reference to U.S. Pat. No. 6,424,847 to Mastrototaro etal., for example.

FIGS. 2A and 2B are perspective and side views of analyte sensor system104 shown in FIG. 1 according to certain aspects of the presentdisclosure. Analyte sensor system 104 may include a mounting unit 214and sensor electronics module 106 attached thereto in certainembodiments, shown in its functional position, where mounting unit 214and sensor electronics module 106 are matingly engaged therein. In someembodiments, the mounting unit 214, also referred to as a housing orsensor pod, comprises a base 234 adapted for fastening to a host's skin.The base 234 can be formed from a variety of hard or soft materials, andcan have a low profile for minimizing protrusion of the device from thehost during use. In some embodiments, the base 234 is formed at leastpartially from a flexible material, which can provide numerousadvantages over conventional transcutaneous sensors that may suffer frommotion-related artifacts associated with movement of the host when thehost is using the device. The mounting unit 214 and/or sensorelectronics module 106 can be located over a sensor insertion site toprotect the site and/or provide a minimal footprint (i.e., utilizationof the surface area of the host's skin).

In some embodiments, a detachable connection between the mounting unit214 and sensor electronics module 106 is provided, enabling improvedmanufacturability. That is, mounting unit 214 (which may be relativelyinexpensive) can be disposed of when replacing continuous analyte sensor108 after its usable life, while the relatively more expensive sensorelectronics module 106 can be reusable with additional, replacementcontinuous analyte sensors 108. In some embodiments, the sensorelectronics module 106 is configured with signal processing(programming) functionality, for example, filtering algorithms,calibration algorithms, and/or other algorithms useful for calibrationand/or the display of sensor information. However, an integral(non-detachable) sensor electronics module 106 is also contemplated foruse in accordance with other embodiments.

In some embodiments, the contacts 238 are mounted on or in a subassemblyhereinafter referred to as a contact subassembly 236 configured to fitwithin the base 234 of the mounting unit 214 and a hinge 248 that allowsthe contact subassembly 236 to pivot between a first position (forinsertion) and a second position (for use) relative to the mounting unit214. The term “hinge” as used herein is a broad term and is used in itsordinary sense, including, without limitation, to refer to any of avariety of pivoting, articulating, and/or hinging mechanisms, such as anadhesive hinge, a sliding joint, and the like; the term hinge does notnecessarily imply a fulcrum or fixed point about which the articulationoccurs. In some embodiments, the contacts 238 are formed from aconductive elastomeric material, such as a carbon black elastomer,through which the continuous analyte sensor 108 extends.

In certain embodiments, the mounting unit 214 is provided with anadhesive pad 208, disposed on a back surface of mounting unit 214 andincludes a releasable backing layer. Thus, removing the backing layerand pressing the base portion 234 of the mounting unit 214 onto thehost's skin 204 adheres the mounting unit 214 to the host's skin 204.Additionally or alternatively, an adhesive pad can be placed over someor all of the analyte sensor system 104 after insertion of a continuousanalyte sensor 108 is complete to ensure adhesion, and optionally toensure an airtight seal or watertight seal around the wound exit-site(or continuous analyte sensor 108 insertion site) (not shown).Appropriate adhesive pads can be chosen and designed to stretch,elongate, conform to, and/or aerate the region (e.g., host's skin 204).The embodiments described with reference to FIGS. 2A and 2B aredescribed in more detail with reference to U.S. Pat. No. 7,310,544,which is incorporated herein by reference in its entirety.Configurations and arrangements can provide water resistant, waterproof,and/or hermetically sealed properties associated with the mountingunit/sensor electronics module 106 embodiments described herein.

Various methods and devices that are suitable for use in conjunctionwith aspects of some embodiments are disclosed in U.S. PatentPublication No. US-2009-0240120-A1, which is incorporated herein byreference in its entirety for all purposes.

FIG. 3 is a block diagram illustrating example components of analytesensor system 104 and at least one of the plurality of display elements120 a, as well as the communications therebetween. The analyte sensorsystem 104 may include an implantable continuous analyte sensor 312 (oneembodiment of continuous analyte sensor 108 of FIG. 1) coupled to asensor measurement circuit 310 for processing and managing sensor data.The sensor measurement circuit 310 may be coupled to a processor 314(part of sensor electronics module 106 in FIG. 1). In some embodiments,the processor 314 may perform part or all of the functions of the sensormeasurement circuit 310 for obtaining and processing sensor measurementvalues from the implantable continuous sensor 312. The processor may befurther coupled to a radio unit or transceiver 316 (part of sensorelectronics module 106 in FIG. 1) for sending sensor information to andreceiving requests and commands from an external device, such as displaydevice 120 a, which is used to display or otherwise provide the sensorinformation to a user. As used herein, the terms “radio unit” and“transceiver” are used interchangeably and generally refer to a devicethat can wirelessly transmit and receive data. The analyte sensor system104 may further include a memory 318 (also part of sensor electronicsmodule 106 in FIG. 1) and a real time clock (RTC) 320 (again, part ofsensor electronics module 106 in FIG. 1) for storing and tracking sensorinformation.

Wireless communication protocols may be used to transmit and receivedata between analyte sensor system 104 and display device 120 a. Thewireless communication protocol used may be designed for use in awireless sensor network that is optimized for periodic and small datatransmissions (that may be transmitted at low rates if necessary) to andfrom multiple devices in a close range (e.g., a personal area network(PAN)). For example, the wireless communication protocol may beoptimized for periodic data transfers where transceivers may beconfigured to transmit data for short intervals and then enter low powermodes for long intervals. The wireless communication protocol may havelow overhead requirements both for normal data transmissions and forinitially setting up communication channels (e.g., by reducing headeroverhead) to reduce power consumption. In some embodiments, burstbroadcasting schemes (e.g., one way communication) may be used. This mayeliminate overhead required for acknowledgement signals and allow forperiodic transmissions that consume little power.

The wireless communication protocol may further be configured toestablish communication channels with multiple display devices, e.g.,two or more of display devices 120, while implementing interferenceavoidance schemes. In some embodiments, the wireless communicationprotocol may make use of adaptive isochronous network topologies thatdefine various time slots and frequency bands for communication withseveral ones of display devices 120. The wireless communication protocolmay thus modify transmission windows and frequencies in response tointerference and to support communication with multiple ones of displaydevices 120. Accordingly, the wireless protocol may use time andfrequency division multiplexing (TDMA) based schemes. The wirelesscommunication protocol may also employ direct sequence spread spectrum(DSSS) and frequency-hopping spread spectrum schemes. Various networktopologies may be used to support short-distance and/or low-powerwireless communication such as peer-to-peer, start, tree, or meshnetwork topologies such as WiFi, Bluetooth and Bluetooth Low Energy(BLE). The wireless communication protocol may operate in variousfrequency bands such as an open ISM band such as 2.4 GHz. Furthermore,to reduce power usage, the wireless communication protocol mayadaptively configure data rates according to power consumption.

Display device 120 a may be used for alerting and providing sensorinformation to a user, such as host 102, and may include a processor 330for processing and managing sensor information. Display device 120 a mayinclude a display 332, a memory 334, and a real time clock 336 fordisplaying, storing and tracking sensor information, respectively.Display device 120 a may further include a radio unit or transceiver 338for receiving sensor information and for sending requests, instructions,and data to the analyte sensor system 104. The transceiver 338 mayfurther employ a wireless communication protocol. The memory 334 mayalso be used for storing an operating system and/or a custom (e.g.,proprietary) application designed for wireless data communicationbetween a transceiver, e.g., transceiver 316 and display device 120 a.The memory 334 may be a single memory device or multiple memory devicesand may be a volatile or non-volatile memory for storing data and/orinstructions for software programs and applications. The instructionsmay be executed by the processor 330 to control and manage thetransceiver 338.

It should be understood that in the case of display device 120 e, whichmay be a medicament delivery device in addition to or instead of adisplay device, the alerts and/or sensor information provided bycontinuous analyte sensor 108 vis-à-vis sensor electronics module 106,can be used to initiate and/or regulate the delivery of the medicamentto host 102.

In some embodiments, when a standardized communication protocol is used,commercially available transceiver circuits may be utilized thatincorporate processing circuitry to handle low level data communicationfunctions such as the management of data encoding, transmissionfrequencies, handshake protocols, and the like. In these embodiments,processors 314 and 330 do not need to manage these activities, butrather provide desired data values for transmission, and manage highlevel functions such as power up or down, set a rate at which messagesare transmitted, and the like. Instructions and data values forperforming these high level functions can be provided to the transceivercircuits 316 and 338, respectively, via a data bus and transfer protocolestablished by the manufacturer of the transceiver circuits 316 and 338.

Components of the analyte sensor system 104 may require replacementperiodically. For example, implantable continuous analyte sensor 312that may be attached to sensor electronics module 106 which itselfincludes the sensor measurement circuit 310, the processor 314, memory318, and transceiver 316, and battery (not shown) may require periodicreplacement (e.g., every 7-30 days). The sensor electronics module 106may be configured to be powered and active for much longer thanimplantable continuous analyte sensor 312 (e.g., for 3 months, 6 monthsor more) until the battery needs replacement. Replacing these componentsmay be difficult and require the assistance of trained personnel.Reducing the need to replace such components, including the battery ifreplaceable, significantly improves the convenience of the analytesensor system 104 to the host 102.

When sensor electronic module 106 is used for the first time (orreactivated once a battery has been replaced in some cases), it may beconnected to implantable continuous analyte sensor 312. As will befurther described below, there may be a process for initiallyestablishing communication between display device 120 a and sensorelectronics module 106 when it is first used or re-activated (e.g., thebattery is replaced). Once display device 120 a and sensor electronicsmodule 106 have established communication, display device 120 a andsensor electronics module 106 may periodically and/or continuously be incommunication over the life of several ones of implantable continuousanalyte sensor 312 until, for example, the battery or the entirety ofsensor electronics module 106 needs to be replaced. Each time continuousanalyte sensor 312 is replaced, notifications of a new continuousanalyte sensor 312 can be sent/exchanged via the previously establishedcommunication between the sensor electronics module 106 and displaydevice 120 a.

In accordance with one embodiment, analyte sensor system 104 gathers andprocesses analyte measurements from continuous analyte sensor 312, andperiodically sends sensor information representative of the analytemeasurements to display device 120 a. Measurements are gathered andtransmitted over the life of continuous analyte sensor 312 (e.g., in therange of 1 to 30 days or more). New measurements may need to betransmitted often enough to adequately monitor analyte levels. Ratherthan having the transmission and receiving circuitry of each of theanalyte sensor system 104 and display device 120 a continuouslycommunicating, the analyte sensor system 104 and display device 120 amay regularly and periodically establish a communication channel betweenthem. Thus, analyte sensor system 104 can communicate wirelessly withdisplay device 120 a at predetermined time intervals. The duration ofthe predetermined time interval can be selected to be long enough sothat the analyte sensor system 104 does not consume too much power bytransmitting data more frequently than needed, yet frequent enough toprovide substantially real-time sensor information (e.g., measuredanalyte values) to one or more of display devices 120 for output (e.g.,display) to a user. While the predetermined time interval is every fiveminutes in some embodiments, it is appreciated that this time intervalcan be varied to be any desired length of time. It should be noted thatother contemplated embodiments involve irregular or aperiodictransmissions of sensor information, e.g., from analyte sensor system104 to one or more of display devices 120.

FIG. 4 is an example advertising/connection sequence between analytesensor system 104 and display device 120 a which is capable ofwirelessly receiving analyte measurement values from the analyte sensorsystem 104 according to certain aspects of the present disclosure. Thevarious tasks performed in connection with the advertising/connectionillustrated in FIG. 4 may be performed by a processor executinginstructions embodied in a non-transitory computer-readable medium. Forexample, the tasks performed in connection with the procedure may beperformed by hardware, software, firmware, or any combination thereofincorporated into one or more of computing devices, such as analytesensor system 104 and display device 120 a of FIG. 1 and/or FIG. 3. Itshould be appreciated that the procedure may include any number ofadditional or alternative tasks. The tasks shown in FIG. 4 need not beperformed in the illustrated order, and the procedure may beincorporated into a more comprehensive procedure or process havingadditional functionality not described in detail herein.

In the example described below, the analyte values are glucose valuesbased on one or more measurements of glucose levels by the implantablecontinuous analyte sensor 312 for illustration purposes. However, itshould be understood that the analyte values can be any other analytevalue described herein. The wireless data communication between theanalyte sensor system 104 and the display device 120 a may happenperiodically, at times separated by an update interval denoted“T_(interval)” that may correspond to a time duration between twoconsecutive wireless communication sessions between the transceiver 316of the analyte sensor system 104 and the transceiver 338 of displaydevice 120 a. Alternatively, the update interval may be thought of as aperiod of obtaining and sending a recently measured glucose value.Transmitting advertisement signals, establishing a data connection(e.g., a communication channel) and requesting and sending data mayoccur during wireless communication sessions each lasting an active timeor period denoted “T_(Active)” within an update interval T_(interval).In between two consecutive wireless communication sessions, thetransceiver 316 goes into an inactive or sleep mode for an inactiveperiod denoted as “T_(inactive)” to conserve battery life and/or reducepeak voltage requirements, for example.

FIG. 4 shows two such wireless communication sessions, namely, a firstwireless communication session 410 and a second wireless communicationsession 420. Each wireless communication session 410, 420 starts withthe analyte sensor system 104 establishing a data connection withdisplay device 120 a. To establish a data connection with display device120 a, the transceiver 316 of the analyte sensor system 104 transmits aseries of advertisement signals 412 during the first wirelesscommunication session 420. Each advertisement signal may be consideredan invitation for display device 120 a to establish a data connectionwith the transceiver 316. In some embodiments, advertisement signals 412may be embodied as advertising beacons, as will be discussed in greaterdetail below.

In the illustrated example of FIG. 4, it is assumed that the analytesensor system 104 needs to engage in an initial system setup because theanalyte sensor system 104 has been just turned on for the first timeand/or is not current paired with display device 120 a. Typically, auser of display device 120 a identifies a new or never-been used analytesensor system 104 that needs to be paired with display device 120 a byentering identification information (e.g., a serial number) associatedwith the new/unpaired analyte sensor system 104 via a custom applicationrunning on display device 120 a using a user interface (e.g., atouchscreen display). During the first wireless communication session410, an authentication procedure can be performed as part of a dataconnection process 414. To establish a data connection with the analytesensor system 120, the display device 120 a listens continuously untilan advertisement signal transmitted by the transceiver 316 of theanalyte sensor system 104 is received. Once the transceiver 316 beginstransmitting advertisement signals 412, it may take one, two, or moreadvertisement signals for the display device 120 a to receive at leastone of the advertisement signals and respond to at least one of theadvertisement signals. In some embodiments, the transceiver 316 stopssending additional advertisement signals once display device 120 areceives an advertisement signal and responds to that advertisementsignal, for example, via an acknowledgement. In other embodiments, thetransceiver 316 may continue to send additional advertisement signalseven after receiving a response from display device 120 a so thatanother display device, e.g., one or more of display devices 120 b-e,may receive and respond to at least one of the additional advertisementsignals. After an advertisement signal is successfully received bydisplay device 120 a, display device 120 a and the analyte sensor system104 engage in a first data connection process 414. During the first dataconnection process 414, the display device 120 a requests a challengevalue from the analyte sensor system 104 and the analyte sensor system104 sends the change value to the display device 120 a in response. Uponreceiving the challenge value, the display device 120 a calculates ahash value based on the challenge value and the identificationinformation associated with the analyte sensor system 104 and/or thetransceiver 316 and sends the hash value to the transceiver 316. Thetransceiver 316 receives the hash value from the display device 120 a,decodes the identification information from the hash value, and verifiesthat the received identification information matches identificationinformation associated with the analyte sensor system 104 and/ortransceiver 316 previously stored in the memory 318 of the analytesensor system 104, such as during manufacturing of the analyte sensorsystem 104. Upon verification, the transceiver 316 sends a signalconfirming a successful authentication to the display device 120 a. Onceauthenticated, the analyte sensor system 104 and display device 120 amay exchange information to determine how data will be exchanged (e.g.,a specific frequency, time slot assignment, encryption, etc.).

After completion of the first data connection process 414, the analytesensor system 104 and now-connected display device 120 a engage in afirst data communication 416 during which display device 120 a requestsand receives desired information (e.g., analyte measurement data,control information, identification information, and/or instructions)from the analyte sensor system 104. When the first data communication416 is completed, the data connection is terminated (e.g., by closingthe established communication channel) and the transceiver 316 and/orthe processor 314 of the analyte sensor system 104 (and possibly thetransceiver 338 and/or the processor 330 of the display device 120 a aswell, depending on implementation preference) can be deactivated bycausing the transceiver 316 and/or the processor 314 to enter a sleep orinactive mode. In some embodiments, the transceiver 316 is completelypowered down during a sleep mode. In other embodiments, the transceiver316 is in a low power mode using only a small fraction (e.g., 1-10%) ofthe normal current/power. As will be discussed further below,transceiver 316 may be woken up, for example, by an NFC on-demandrequest from one of display devices 120 for sensor information to besent to another one of display devices 120, e.g., display device 120 a,accelerometer movement that triggers a wake up of transceiver 316, etc.It should be noted that in some embodiments, advertising signalsthemselves can have specific headers so that directed or targetedadvertising can be performed. For example, one of display devices 120listed in a whitelist (discussed in greater detail below) may notrespond to advertising signals unless the advertising signals aredirected specifically to that display device.

The active period T_(Active) corresponding to a duration of eachwireless communication session may be a small fraction of the updateinterval T_(interval) corresponding to a period between two consecutivewireless communication sessions. For example, T_(interval) may bebetween about 200 and 400 seconds and T_(Active) may be between 20 and40 seconds. As such, the transceiver 316 of the analyte sensor system104 may be powered fully for only 10 percent (e.g., 30 seconds) of afive minute T_(interval). This may significantly reduce powerconsumption and peak voltage demand. In some cases, the transceiver 316is not completely powered down, but enters a low-power mode when nottransmitting. After an inactive time or period T_(Inactive), a secondwireless communication session 420 starts when the transceiver 316 (andthe transceiver 338) powers up again, begins transmitting a secondseries of advertisement signals 422, engages in a second data connectionprocess 424 and a second data communication process 426 with thetransceiver 338 of display device 120 a as shown in FIG. 4. Unlike thefirst data connection process 414, however, the second data connectionprocess 424 need not involve an authentication procedure because theanalyte sensor system 104 and the display device 120 a have beensuccessfully paired or bonded during the first wireless communicationsession 410 as described above. This process may continue, with new dataconnections and communications being completed at the pre-determinedintervals. During all or part of each inactive period T_(Inactive)during which the transceiver 316 is in a sleep mode, the processor 314can take measurement(s) of one or more analyte values using the analytesensor 312 and the sensor measurement circuitry 310. For example, theprocessor 314 may take multiple analyte value measurements and averagethem to generate a single averaged analyte value to be transmitted in anext wireless communication session.

Continuously re-establishing a new communication channel to allow forpartially or wholly powering down the transceiver 316 during each updateinterval T_(interval) can provide significant power savings and canallow the sensor electronics module 106 (FIG. 1) to operate continuouslyfor, e.g., 1 month, 3 months, 6 months, 1 year, etc., without requiringa battery replacement. It should be noted that in some embodiments,battery replacement may be a function of the actual expiration ofbattery power or some predetermined level of remaining battery power.Furthermore, rather than blindly transmitting glucose data points duringthe update interval T_(interval), establishing specific data connections(e.g., communication channels) with only desired display devices, e.g.,display device 120 a, can prevent unauthorized use and interception ofglucose measurement values. In some embodiments, only a subset ofmultiple display devices 120 can be configured to receive different datasuch as glucose measurement values and/or alarm conditions. For example,in addition to a display device identifier(s), a whitelist may bepopulated with a data type identifier indicative of a type of data to besent to that particular display device(s) populating the whitelist. Inother embodiments, the sensor electronics module 106 may bepre-programmed with preference or profile information, which can beaccessed to determine what type(s) of data are to be sent to whatdisplay device(s). Thus, prior to the exchange of sensor information,the sensor electronics module 106, for example, can access the whitelist(or bonding list in some embodiments) and/or preference/profileinformation to determine what type(s) of data should be sent to adisplay device. In still other embodiments, initial communicationsbetween sensor electronics module 106 and a display device, the displaydevice can transmit type information to sensor electronics module 106.This has a benefit of preventing all of display devices 120 from issuingalarms, thereby confusing and/or frustrating the user. In addition, byestablishing a secure two-way communication channel, requests forspecific glucose measurement values or communication of calibration orconfiguration information may be transmitted on an as-needed/requestedbasis between the analyte sensor system 104 and display device 120 a.

Also, in some embodiments, the transceiver 316 may not be activated fordata communication every update interval T_(interval). Instead, thetransceiver 316 may be activated every second, third or fourth updateinterval T_(interval), for example, so that communication between theanalyte sensor system 104 with the display device 120 a occurs lessfrequently than every update interval T_(interval). Doing so can furtherreduce power consumption. Activation could also depend on the sensorinformation. For example, the transceiver 316 need only be activated ifdata meets certain thresholds, such as a current rate of change, currenthigh value, current low value, absolute difference from a previouslyexchanged value, percentage difference from a previously exchangedvalue, and the like. In some embodiments, instead of skipping certainfixed update intervals, the length of each interval can be made to varybased on the sensor information or other criteria. For example, if thesensor information indicates a low glucose value and/or a hypoglycemicreaction is detected, the update interval value can be shortened from anormal (longer) update interval value so that more frequent readings aretaken and/or transmitted.

In some embodiments, one or more of the update interval T_(interval),the active period T_(Active) and a frequency F_(Activation) by which thetransceiver is activated (e.g., every second, third or fourth updateinterval) may be variable. In certain embodiments, the above-identifiedparameters can be user configurable (e.g., by inputting a value for thevariable using user interface of display device 120 a) and/orautomatically varied by the analyte sensor system 104 or display device120 a based on one or more criteria. The criteria can include: (i) amonitored battery power of the sensor system 104, (ii) a currentlymeasured, previously measured and/or predicted glucose concentrationsmeeting or exceeding a predetermined threshold, (iii) a glucoseconcentration trend of the host based on currently measured, previouslymeasured and/or predicted glucose concentrations, (iv) a rate of changeof glucose concentration of the host based currently measured,previously measured and/or predicted glucose concentrations meeting orexceeding a predetermined threshold, (v) whether the host is determinedto be in or near hyperglycemia based on currently measured, previouslymeasured and/or predicted glucose concentrations, (vi) whether the hostis determined to be in or near hypoglycemia based on currently measured,previously measured and/or predicted glucose concentrations, (vii) userinputted activity of the host (e.g., exercising or sleeping), (viii)time since a sensor session has started (e.g., when a new sensor 10 isused), (ix) one or more errors detected by sensor system 104 or displaydevice 120 a and (x) type of display device 120 a (where the displaydevice 120 a can be connected or populating the whitelist or bondinglist).

T_(interval), T_(Active), F_(Activation) and/or other configurationitems described herein may form part of a communication protocol profilethat may be stored on any device that implements the fundamentalcommunication protocol to allow for a customized use of the protocol forcommunicating analyte measurement values in the analyte sensor system104 and one or more of display devices 120.

Power Savings and Connection Reliability

As discussed above, reducing the need to replace componentssignificantly improves the convenience of the analyte sensor system 104to the user. Accordingly, various embodiments are directed to powersaving schemes and/or mechanisms to increase battery life of analytesensor system 104, e.g., sensor electronics module 106. Althoughgeneralized concepts of putting a transceiver, such as transceiver 316,into a sleep or low power mode, and continuously re-establishing a newcommunication channel to allow for partially or wholly powering downtransceiver 316 have been described, specific parameters or variablesfor communicating as well as conditions for dictating how those specificparameters or variables are adjusted will be further discussed below.The result of adjusting such parameters or variables as governed bycertain communication conditions are efficient systems and methods forinitiating or requesting communications (intelligent advertising) aswell as transmitting data (intelligent communications).

Still another result of the adjustment of parameters and variables inresponse to communication conditions is increased connection reliabilitybetween analyte sensor system 104, e.g., sensor electronics module 106,and one or more of display devices 120. For example, and in the contextof advertising, advertising variables can be set or selected based onsome minimum reliability to avoid or lessen the occurrence of missedadvertising beacons when the advertising interval is short (to avoidexcessive battery drain on sensor electronics module 106 as a result oflonger advertising intervals). Thus, the optimizing of communications isin and of itself an advantage realized by various embodiments beyond theincrease in power savings.

Radio Software and Architecture

From a radio design/implementation perspective, the radio software andarchitecture utilized to implement various embodiments are configured inaccordance with intelligent advertising and communicationconsiderations. Accordingly, various embodiments implement radiosoftware based on background and foreground processing for applicationcontrol, where the foreground processing can be referred as “main-loop”processing, which manages wireless connections and passing data withinsensor electronics module 106 using four commands with sleep (low powermode) support. The four commands include “start communication,” “stopcommunication,” “CGM receive,” and “CGM transmit” and will be describedin greater detail below.

FIG. 5 is a block diagram illustrating various elements of sensorelectronics module 106 (of FIG. 1) involved in the transmission ofsensor information in a continuous analyte monitoring system 100 inaccordance with various embodiments described in the present disclosure.It should be noted that the following embodiments are described in thecontext of a continuous glucose monitoring (CGM) system (an embodimentof continuous analyte monitoring system 100), where one example wirelesscommunication protocol used for communications between analyte sensorsystem 104 and one or more of display devices 120 is the Bluetooth® LowEnergy (BLE) standard. However, it should be understood that othercontinuous analyte monitoring systems and other transceivers or radiosmay be utilized such as those operating in accordance with other lowpower/short-range communications protocols.

After startup or powering on of sensor electronics module 106, a radio508 is initialized and may enter a “sleep mode” waiting for a commandfrom a CGM processor 506. It should be appreciated that radio 508 may bean embodiment of transceiver 316 (FIG. 3), CGM processor 506 may be anembodiment of processor 314, and the sleep mode may refer to one of theinactive periods T_(inactive) described with reference to FIG. 4. AnAnalog Front End (AFE) 500 initializes to its default state and alsowaits for configuration commands.

FIG. 6 illustrates an example transceiver processing/connection sequencewhich will be described in conjunction with the elements of sensorelectronics module 106 shown in FIG. 5. Whereas FIG. 4 and itscorresponding description provide a broader description of wirelesscommunications between analyte sensor system 104 and display device 102a, FIG. 6 describes the wireless communications from a more detailedperspective of the one or more components comprising sensor electronicsmodule 106.

As illustrated in FIG. 6, radio 508 is operative to transmitadvertisements (e.g., advertisements 412 of FIG. 4). Such advertisementsmay comprise small packets of data broadcast at, e.g., regularintervals. In particular, advertising may be a one-way communicationmethod, where system elements that want to be discovered (such asdisplay devices, when analyte sensor system 104 wishes to send sensorinformation to be displayed on at least one display device 120)broadcasts advertisement beacons or packets in predetermined intervals.Upon receipt of such advertisements, at least one of display device 120can establish communications with analyte sensor system 104 (dataconnection process 414 of FIG. 4) to receive sensor information, forexample, and display the sensor information (e.g., analyte and/orestimated glucose values), initiate an alarm, etc.

CGM processor 506, as described above, may be one embodiment of theaforementioned processor 314, which can take a measurement(s) of one ormore analyte values, in this example, glucose values, using implantablecontinuous analyte sensor 312 and sensor measurement circuitry 310 orAFE 500. For example, CGM processor 506 may take multiple glucose valuemeasurements and process the multiple glucose value measurements (e.g.,via one or more processing algorithms, noise filters, etc.) to arrive atone or more transformed glucose values to be transmitted via radio 508.Moreover, AFE 500 may be one or more sets of analog signal conditioningcircuitry utilizing, e.g., operational amplifiers, filters, ASICs,and/or other circuitry to allow the sensor to interface with CGMprocessor 506.

In accordance with some embodiments, staged task processing may beutilized to limit the run-time of processors (i.e., CGM processor 506and radio 508) to avoid overlapping as much as possible, therebyreducing stress on the battery (and minimizing asynchronous messagingissues). In particular, and after initialization, AFE 500 samples rawsensor data 504 for, e.g., 5 minutes, while CGM processor 506 and radio508 are in low power mode (a T_(inactive) period of FIG. 4). Once AFE500 is ready, a wake event is triggered by sending a “wake up” messageto CGM processor 506 (process 600) causing the processor 506 to beawake, and during which raw sensor data transfer between AFE 500 and CGMprocessor 506 can be completed (process 602). AFE 500 may then return tolow power mode acquisition of raw sensor data, for example. CGMprocessor 506 then calculates and stores estimated glucose value (EGV)data (process 604). CGM processor 506 may signal radio 508 to “startcommunication,” (process 606) after which CGM processor 506 enters lowpower mode (process 608).

The start communication command is the first command radio 508 sees andcan include data such as a transmitter ID, a communication interval,system mode, RTC value, and API version. Sending such data with eachstart command allows radio 508 to reset without having to issue anasynchronous command for configuration data. It also allows CGMprocessor 506 to control the state of radio 508 dynamically (i.e.setting storage mode). Once the start communication command isacknowledged, CGM processor 506 enters low power mode. It should benoted that CGM processor 506 can be designed to stay in sleep mode untilreal-time events and data processing is complete, thus minimizing mainloop processing current draw to save battery power.

Radio 508 may begin advertising, and if one of display devices 120,e.g., display device 120 a, creates a radio frequency (RF) link (process610) (i.e., a wireless communication session is initiated andestablished per the transmission of advertisement signals 412 and dataconnection establishment 414 of FIG. 4), display device 120 a and CGMprocessor 506 exchange commands/data (processes 612, also referred toas, e.g., first data connection 416, second data connection 426, etc. ofFIG. 4). It should be noted that when display device 120 a (not shown inFIG. 6) is connected, sensor electronics module 106 enters a “connectionrequest mode,” the purpose of which is to remove the asynchronousmessaging complexity from the RF communication link. This connectionrequest mode can be implemented using, e.g., control point/indicationresponses of the wireless communication protocol being utilized.Moreover, a connection request/response protocol may be used for allmessages, where display device 120 a only issues connection requests,and radio 508 only issues connection responses. Moreover, radio 508 maybe placed in a connection “pass-thru” mode, using a message transportlayer, and CGM processor 506 may process the appropriate connection(processes 614, 616). When display device 120 a has an active RFcommunication link, both the CGM application and radio application arein low power mode. The radio stack keeps the RF communication link open,and only when a connection request is sent from display device 120 a,will the radio/CGM applications exit low power mode.

In particular, a CGM receive command is triggered when the displaydevices sends a connection request on the wireless communicationsprotocol API. This command takes the payload and sends it to CGMprocessor 506. In some embodiments, the payload is 20 bytes and anyextra room is used to send real-time radio status data to CGM processor506 for every command received. As described previously, the content ofdata packages, for example, can be customized depending on the displaydevice type. Thus, in some embodiments, an indication of the type ofdisplay device that is active (currently engaged in data communicationswith analyte sensor system 104) can be provided in the payload. A CGMtransmit command comprises a response to a display command request forperforming the reverse operations of the CGM receive command, i.e., ittakes the payload and sends it to the radio stack to be transmitted onthe RF link. A stop communication command may be used to ensure radio508 does not exceed a predefined “communication window,” which in someembodiments is, e.g., 30 seconds, since RF noise can affect AFE sensormeasurements. This stop command accordingly can be sent, e.g., 26seconds after the start communication command is sent.

It should be further noted that radio 508 may also enter low power modewhile CGM processor 506 is processing the connection request (process618) and there are no main loop tasks to process. Once the displaydevice 102 a and CGM processor 506 complete the exchange ofcommands/data, both CGM processor 506 and radio 508 can enter low powermode (process 620 and also referred to as a T_(inactive) period of FIG.4).

Battery Life

As previously discussed, various embodiments are directed tomaximizing/preserving battery life. To that end, sensor electronicsmodule 106 is configured to operate in two low power modes, a storagemode and an active mode, with a wake source being utilized to wakesensor electronics module 106 from low power mode.

Storage mode (also referred to as shelf mode) is a mode in which sensorelectronics module 106 is placed before being packaged. In accordancewith one embodiment, sensor electronics module 106 can stay in this modeuntil it detects a sensor has been inserted and, at that time,automatically enters active mode. Storage mode places radio 508 in “deepsleep” as well as places CGM processor 506 into a no-clock mode to keepbattery power consumption to absolute minimum levels. Active mode alsoimplements a low power mode, but leaves the real-time clock active. Thisresults in current being drawn, but allows CGM processor 506 to keepaccurate time. Wake source 502 is a periodic event that wakes sensorelectronics module 12 from low power mode and triggers it to startprocessing. Wake source 502 is typically provided by AFE 500, and thisevent first wakes up CGM processor 506 to configure system hardware andsoftware to transfer raw sensor data 504.

Certain wireless communication protocols, such as the aforementioned BLEprotocol, use a client/server model. For example, sensor electronicsmodule 106 (including radio 508), also referred to as a peripheral, mayact as a server while a display device (e.g., display device 120 a),also referred to as a central, acts as a client. The peripheral makesadvertisements as described above (e.g., 412, 422 of FIG. 4), while thecentral scans for advertisements. This model can operate using theconcept of a Generic Attribute Profile (GATT) which defines how a serverand client transfer data back and forth based on “services” (breaking updata into logic entities that contain data referred to as“characteristics”) once a data connection has been established.

Advertising/Connection Protocol

In accordance with various embodiments, an advertising and connectionprotocol may be used to control how often and/or when sensor electronicsmodule 106 (the peripheral) advertises for and connects to one or moredisplay devices 120 (the central(s)). The advertising and connectionprotocol can allow for many different advertisement/connectionscenarios. For example, the advertising and connection protocol can:advertise for and connect to a single central at a time; advertise for aplurality (e.g., two) centrals on each communication interval; andconnect to a plurality of unique types of centrals on each communicationinterval. A connection order priority can be implemented for thedifferent types of centrals, where each type of central may have aunique advertising interval and/or timeout period as will be discussedin greater detail below.

The advertising and connection protocol may utilize “clear text dataexchange” as well as “encrypted data exchange.” Moreover, theadvertising and connection protocol may include various categories ormodes of advertising. One mode can be referred to as generaladvertising, another mode can be referred to as whitelist advertising,and still another mode can be referred to as directed advertising.General advertising refers to a mode where any central can connect withthe peripheral, whereas whitelist advertising refers to a mode ofadvertising in which all connection requests from centrals to theperipheral may be denied except for a connection request from a targetedcentral. Directed advertising may occur if a user wishes to request thatthe peripheral transmit sensor information to a desired central, e.g.,in the case of a NFC-enabled display device 120 c “tapping” analytesensor system 104 to request a connection therebetween.

During general advertising, the whitelist may be empty, and populatedwith, e.g., a Generic Access Profile (GAP) Address or an IdentityResolving Key (IRK) entry upon a display device, i.e., a dedicateddisplay device 120 a, sending its configuration during a bondingexchange when a wireless connection is being established. It should benoted that the whitelist can be dynamically updated to reflect a desiredpriority for advertising and connection. For example, processor 314 ofFIG. 3 can store connection statistics or history in memory 318 suchthat a certain one of display devices 120 is preferred over anotherbased on time, location, and/or other considerations. The whitelist canalso be dynamically updated based upon most recent connections. That is,bonded devices maintained in the bonding list and be filtered inaccordance with the historical statistics and/or recent connectionsinformation to create the whitelist.

FIG. 7A illustrates an example advertising sequence or profileassociated with the advertising and connection protocol. As discussedabove, radio 508 may be in low power mode when CGM processor 506 iswoken up via wake source 502. CGM processor 506 may then transmit rawsensor data 504 from AFE 500, apply one or more algorithms tocreate/calculate an EGV value, and store that EGV value in memory, e.g.,flash database. At this point, advertising can begin and CGM processor506 can signal radio 508 to start advertising (e.g., 3 seconds after thewake event).

Radio 508 may advertise to one or more display devices/centrals, e.g., ahandheld mobile device or a dedicated receiver, such as a CGM displaydevice. As illustrated in FIG. 7A, radio 508 may send first advertisingbeacons 700 (also referred as advertisement signals 412 in FIG. 4) at acertain interval referred to as an advertising interval, A_(ip), e.g.,90 ms. Such advertising beacons 700 are sent according to theadvertising interval A_(ip) for a predetermined time referred to as anadvertising duration, A_(dp). The advertising duration A_(dp) isconsidered to be an amount of time radio 508 will transmit advertisingbeacons to one or more of display devices 120. In this example, theadvertising duration A_(dp) for a handheld device such as display device120 c may be 7 seconds. In the event a connection is made, advertisingwill end so that a wireless connection can be established. Radio 508 mayalso send second advertising beacons 702 to advertise to the CGM displaydevice, e.g., display device 120 a. Again, advertising beacons 702 aretransmitted in accordance with a particular advertising interval,A_(ir), which can be the same or different than advertising intervalA_(ip), for some advertising duration A_(dr), which can be the same ordifferent than advertising duration A_(dp). For ease of reference,advertising interval may be generally described as A_(i) and advertisingduration may be generally described as A_(d), where the aforementionedA_(ip), A_(ir), A_(dp), and A_(dr), are examples of advertisingintervals and durations associated with particular ones of displaydevices 120, discussed in greater detail below.

Advertising intervals, e.g., A_(ip) or A_(ir) and/or advertisingdurations, e.g., A_(dp) or A_(dr), may differ due to the type of displaydevice/central to which radio 508 is advertising. In the above-describedexample, one display device, display device 120 c, may be a handhelddevice, such as an iPhone®, which, due to its communication(s)characteristics stemming from the fact that it is a general purposehandheld device may necessitate a longer advertising duration A_(dp) inorder to receive an advertising beacon 700 and send a connection requestback to radio 508. The CGM display device, i.e., display device 120 a,being a dedicated receiver, may not need as long an advertising durationA_(dr) because it is specifically configured to communicate with radio508 of analyte sensor system 104. As alluded to above and discussed ingreater detail below, advertising interval, e.g., A_(ip) or A_(ir)themselves may also differ based on the sensor information to becommunicated to the display device, historical performance, etc.Additionally, and as discussed previously, different types ofadvertising can be achieved in accordance with various embodiments. Forexample, in whitelist advertising, only a targeted display device isallowed to engage in data exchange with sensor electronics module 106,where advertising beacons, such as advertising beacon 700 may include aspecifically configured header or other identifier targeting a specificdisplay device. Referring to FIG. 7B, if the connection request comesfrom the targeted display device, establishment of the connection canproceed. However, if the connection request comes from an un-targeteddisplay device, connection establishment will not occur. As to directedadvertising, a user may use an NFC-enabled display device 120 c to,e.g., wake up sensor electronics module 106, which in turn may advertiseto a particular display device, e.g., display device 120 a, withadvertising beacons targeted to display device 120, i.e., advertisingbeacon 702 having an advertising interval, A_(ir), and advertisingduration, A_(dr). In one example, in addition to waking up the sensorelectronics module 106, during the NFC based communication, the targeteddisplay device may provide an advertising request to the sensorelectronics module 106. In addition, the display device may, in someexamples, may provide preferred advertisement intervals andadvertisement durations parameters to the sensor electronics module. Theelectronics module 106 may then advertise to the targeted display deviceaccording to the provided parameters.

It should be noted that display devices contemplated by the presentdisclosure need not be limited to mobile communication devices, such assmart phones, and dedicated receivers, but can include any type ofreceiver appropriate for receiving sensor information in one or moreforms/formats. For example, another type of display device/central maybe a smart watch, e.g., display device 120 b. In accordance with variousembodiments, sensor electronics module 106 can categorize displaydevices based on their ability to scan, connect, and/or act as a proxy.That is, display device 120 a, an example of a dedicated receiver in oneembodiment, can connect only to analyte sensor system 104 via sensorelectronics module 106, and may also scan for transmission packets(e.g., advertising beacons 700, 702 or EGV values) from radio 508 if acommunication link is lost or dropped. Display device 120 c may connectto analyte sensor system 104 via sensor electronics module 106, but mayalso connect to other devices, e.g., a WiFi access point, a mobilecommunications network, etc. Additionally, a handheld device, such asdisplay device 120 c, like a customized display device, i.e., displaydevice 120 a, may scan for transmission packets and may also act as aproxy for sending sensor data such as EGV data to a scan display. Adisplay device, such as the aforementioned smart watch, i.e., displaydevice 120 b, may be categorized as being a “scan only” device, capableonly of scanning for transmission packets with regard to analyte sensorsystem 104 if an existing connection is lost or dropped. That is, a scanonly device cannot wirelessly connect directly to radio 508. As will bediscussed in greater detail below, the capabilities of such displaydevices may change in other embodiments.

FIG. 7B illustrates an advertising and connection sequence or profilesuch as that illustrated in FIG. 4 in accordance with one example.Similar to the example illustrated in FIG. 7A, radio 508 may be in lowpower mode when CGM processor 506 is woken up via a wake event from wakesource 502. CGM processor 506 may then obtain raw sensor data 504 fromAFE 500, apply one or more algorithms to create/calculate an EGV value,and store that EGV value in memory, e.g., a flash database. At thispoint, advertising can begin and CGM processor 506 can signal radio 508to start advertising (e.g., 3 seconds after the wake event). Radio 508may advertise to, e.g., display device 120 c, by sending advertisingbeacons/packets 700 in accordance with advertising interval A_(ip).Although the predetermined advertising duration A_(dp) for displaydevice 120 c may be 7 seconds, in this example, display device 120 c towhich advertising beacons 700 are targeted sends a command (connection)request sooner, reflecting a certain time-til-connection value, C_(ip).Time-til-connection value, C_(ip) is an example of a time-til-connectionvalue, C_(t), associated with the time it takes for a display device, inthis case, display device 120 c, to transmit a connection request toradio 508 in response to an advertising beacon broadcast by radio 508.Thereafter, a wireless connection is established between display device120 c and radio 508. A connection duration, generally described asC_(d), can refer to the time period during which a display device isconnected/in communication with radio 508. In this example, time periodC_(dp) specifies a connection duration for display device 120 c. Oncethe requested commands have been processed, radio 508 may resumeadvertising, e.g., to another display device (advertising beacons 702).As will also be discussed below, varying connection duration and/orvarying advertising and connection parameters based upontime-til-connection values can help extend battery life in accordancewith various embodiments.

FIG. 7C illustrates an example operating interval/frequency oftransmission, O_(i), which is indicative of time between when radio 508is in low power mode/sleeping and when radio 508 wakes up and begins toadvertise (as illustrated in FIG. 6). For example, if display device 120a has an active RF communication link, both the CGM application andradio application are in low power mode. The radio stack keeps the RFcommunication link open, and only when a command request is sent fromdisplay device 120 a, will the radio/CGM applications exit low powermode.

Adjustable Variables

A plurality of options exist for varying or adjusting aspects of theadvertising and connection protocol to minimize processing tasks,conserve battery power, improve connection reliability, etc. Inaccordance with some embodiments, one or more of the aforementionedcommunication aspects of the advertising and connection protocol can betreated as an adjustable variable.

Transmission Variables

Examples of communication variables include those aspects of theadvertising and connection protocol relevant to the manner in which datais transmitted, e.g., transmission frequency or operating interval(e.g., T_(active) of FIG. 4, O_(i) of FIG. 7, etc.), the transmissionprotocol utilized (Bluetooth, WiFI, NFC, ANT+, Zigbee, etc.), whethercommunications are one-way or two-way, and whether data is transmittedon-demand or whether the transmission of data occurs automatically. Forexample, it may be desirable to optimize communications based on thedesired transmission protocol and/or transmission type to avoid wastingradio resources and/or battery life. In accordance with one embodiment,communication variables are adjusted to meet the desired transmissionprotocol and/or transmission type. In particular, and if, for example,the desired communication type is one-way communication, e.g.,transmitting EGV data embedded in advertising beacons 700 and 702 fromsensor electronics module 106 to display devices 120 a and 120 c, CGMprocessor 506 and radio 508 can be instructed/configured to operate suchthat no time is “set aside” for a connection duration C_(d), i.e.,C_(d)=0. Alternatively, CGM processor 506 and radio 508 can beinstructed/configured to operate without any connection duration, C_(d).

Advertising Variables

Other examples of communication variables include aspects of theadvertising and connection protocol, and may include the following: howa data packet is formatted, e.g., the advertising beacon packet mayinclude sensor data rather than merely radio identification information,scan device data, etc.; the manner in which a data packet is encrypted;the advertising duration A_(dx); the advertising interval A_(ix); andthe power used when broadcasting advertisements (e.g., dBm of radio508).

Referring to the above example, and as illustrated in the example ofFIG. 7A, the advertising durations, e.g., A_(dp), A_(dr), can abut eachother if communications are one-way. Again, this may be the case if EGVmeasurements or EGV trend information is included in one or moreadvertising beacons 700, 702 and connections to display devices 120 aand 120 c are not warranted/needed. Moreover, the advertising durationA_(d) and advertising interval A_(i) may be decreased because radio 508is not expecting to establish an actual wireless communication sessionwith display devices 120 a and 120 c. Operating interval O_(i) cancommensurately be increased. In some embodiments, the configuring ofadvertising durations, A_(d), may be ignored or bypassed altogether.

Still other examples of communication variables include the type of thedisplay device (e.g., general purpose handheld device such as displaydevice 120 c, dedicated receiver such as display device 120 a,diagnostic device, consumer device, etc.); the number of display devicesavailable to connect to the analyte sensor system 104; the order inwhich the display devices 120 connect to the analyte sensor system 104;how and/or whether or not a display device is determined to be a primarydisplay device; and the broadcast mode commensurate with the role(primary or peripheral) of the display device.

As can be appreciated, and as alluded to previously, advertisingintervals A_(i) and advertising durations A_(d) may be varied accordingto the type of display device for which the advertising beacons areintended. For example, display device 120 a, a dedicated CGM displaydevice, may have a shorter advertising duration A_(dr) than that ofdisplay device 120 c, a handheld device, e.g., mobile phone. Inaccordance with another example, in a scenario where only a singledisplay device, e.g., display device 120 c, has been able to connect toradio 508, its respective advertising duration A_(dp) may be increasedin order to ensure that sensor information is transmitted and observableby a user. In the event that more than one of the display devices 120have established previous wireless connection sessions with radio 508(e.g., by accessing and reviewing the bonding list), respectiveadvertising durations A_(d) may be shortened under the assumption thatestablishing a wireless connection session between sensor analyte system104 and any particular one of display devices 120 is less critical.

Conditions for Adjusting Variables

As discussed above, certain communication variables can be adjusted toaffect battery usage and improve connection reliability. The manner inwhich those communication variables can be adjusted may be dependentupon one or more conditions for communication described in greaterdetail below that include, but are not limited to display devicespopulating the whitelist and/or bonding list that can be indicative ofhistorical and/or predictive connections, as well as the condition ofthe user/host 102.

Whitelist, Current and Historical Communications/Connections, and Time

Examples of communication conditions upon which adjusting theabove-described communication variables are based can include conditionshaving to do with which display device(s) populate the whitelist and/orwhich display device is currently connected or unconnected. Returning tothe above example, the existence of multiple display devices 120 toconnect to, which can result in a decrease in respective advertisingdurations A_(d) may be based upon multiple display devices 120populating the whitelist, while an advertising duration A_(d) may beincreased in the event that only one corresponding display device, e.g.,display device 120 a, populates the whitelist.

Another example of communication conditions can include historical orprevious communications such as the following: the number of previouslymissed communications; a previous advertising interval/duration“budget;” and historical time-til-connection associated with aparticular display device. That is, CGM processor 506 may remove adisplay device populating the whitelist in the event that apredetermined threshold amount of time during which the display devicehas failed to connect with sensor electronics module 106 has beenexceeded. Still other examples of communication conditions may include,e.g., the time of the last communication with one or more displaydevices and/or a current time of day or date. That is, if the number ofpreviously missed communications, i.e., advertising beacons, such asadvertising beacons 700 for display device 120 c go unanswered for somepredetermined time threshold, the advertising duration A_(dr) fordisplay device 120 c may be reduced or eventually set to 0. This may bethe case, for example, if a user returns to his/her home and turnshis/her mobile phone off or stores it in some location not reachable bythe currently implemented wireless communication protocol. Similarly andregarding previous advertising interval/duration budget, the CGMprocessor 506 may have radio 508 advertise to one or more of displaydevices 102 in accordance with a previous advertising interval, A_(i)and duration, A_(d) unless missed communications and/or historicaltime-til-connection statistics indicate to the CGM processor 506 thatthe advertising interval, A_(i) and duration, A_(d) should be adjustedto comport with current communication conditions. For example, CGMprocessor 506 can review historical time-til connection C_(tp) valuesassociated with display device 120 c. If the time-til connection C_(tp)values are short (e.g., in the event that the user is at work and mayconsistently have his/her phone in his/her possession), CGM processor506 can advertise to display device 120 c in accordance with a shortenedadvertising duration A_(dp). In other words, communication conditions inwhich a display device connects sooner than expected can be interpretedby CGM processor 506 to indicate that connection reliability issufficiently good and that the current advertising interval/durationbudget may be too generous thereby resulting in an unnecessaryexpenditure of battery power.

Sensor Data and User/Sensor Condition

In accordance with some embodiments, communication conditions upon whichadjusting communication variables are based may include a usercondition. For example, depending on one or more of actual and/orpredicted sensor or EGV data or sensor or EGV data trends can affect oneor more communication variables. The same may be true of alarm or alertconditions, e.g., low, high, trending, or boundary alarms. The conditionof sensor analyte system 104 itself, such as whether or not sensorcalibration of continuous analyte sensor 108 is required, completed, orresults in error, or whether continuous analyte sensor 108 is nearing orat the end of its useful life can affect one or more communicationvariables. Temperature of host 102 is also another communicationcondition, as is sensed physical movement. Additionally, signal noise isyet another communication condition that may be measured and relied uponas a basis for adjusting one or more communication variables.

FIG. 8A is a flow chart illustrating example processes performed foradvertising, connecting to, and communicating analyte data in accordancewith various embodiments. At operation 800, a wake event is received,e.g., by a CGM processor 506 of the analyte sensor system 104. Atoperation 802, sensor information is received by the CGM processor 506.At operation 804, analyte data, e.g., EGV data, is calculated and storedby the CGM processor 506. For example, the sensor information receivedby CGM processor 506 may be raw sensor data, which can then be processedto arrive at the analyte value data. In some embodiments, the sensorinformation, e.g., raw sensor data, can be passed to CGM processor 506directly. At operation 806, one or more communication conditions isdetermined as described above. That is, conditions that may have aneffect on the advertising to one or more of display devices 120 and/orresulting wireless communication sessions established between the one ormore display devices 120 and CGM processor 506 can be considered foradjusting or optimizing communication variables. At operation 808, atransceiver, e.g., radio 508, is instructed to advertise to at least afirst display device, e.g., display device 120 c, in accordance with oneor more communication variables (e.g., A_(ip), A_(dp), C_(tp)) basedupon the one or more communication conditions. At operation 810, thefirst display device, display device 120 c, may connect to thetransceiver, radio 508, of analyte sensor system 104. At operation 812,analyte data is transmitted to the first display device, display device120 c. It should be noted that as will be discussed below, a myriad ofdifferent/alternative advertising and/or communication schemes can beused. Accordingly, at operation 814, the transceiver, radio 508 of theanalyte sensor system 104 may connect to and/or transmit analyte valuedata to a second display device, e.g., display device 120 a. As willalso be discussed below, the first and second display devices mayconnect to each other in addition to or as an alternative to connectingto the analyte sensor system 104.

FIG. 8B illustrates a plurality of communication conditions 806 a-806 f(discussed previously) that may be determined or measured in accordancewith operation 806 of FIG. 8A. FIG. 8C illustrates a plurality ofadvertising, communication, and display device-based variables that canbe adjusted in accordance with operation 808 of FIG. 8A.

Intelligent Advertising

As previously discussed, various embodiments contemplate adjusting oneor more variables based on one or more communication conditions in orderto optimize the advertising and connection process such that advertisingand connections can be achieved with sufficient reliability to providemeaningful sensor data while extending battery power. In other words,various embodiments achieve a balance between battery power andconnection reliability. For example, and in the context of advertising,advertising variables can be set or selected based on some minimumreliability to avoid or lessen the occurrence of missed advertisingbeacons when the advertising interval is short (to avoid excessivebattery drain on radio 508 as a result of longer advertising intervals).

In some embodiments, the order of display devices 120 and/or which ofdisplay devices 120 connect to sensor electronics module 106 can impactbattery power and/or connection reliability. Accordingly, whitelistconditions can be determined. That is, CGM processor 508 can access thewhitelist to determine which display device(s) 120 are currently presentwithin the whitelist. For example, CGM processor 508 may adjust theadvertising interval/duration budget to include only the requisiteadvertising interval/duration for display devices present in thewhitelist so that, as previously described, battery power and radioresources are not wasted, e.g., by advertising to display devices thathave a low likelihood of connecting. Thus, advertising beacons are notsent to display devices not currently included in the whitelist.Moreover, advertising to only those display devices present in thewhitelist can result in the ability to provide, e.g., a greateradvertising duration for those display devices, thereby increasingconnection reliability. That is, if an advertising duration has anX-second budget for advertising to display device 120 c (e.g., X_(p)seconds) and display device 120 a (e.g., X_(r) seconds), but displaydevice 120 a is not present in the whitelist, the radio 508 can beinstructed to allocate an additional X_(r) seconds (or some amount oftime based on X_(r) seconds) when advertising to display device 120 c,or to advertise to another display device 120 b, d, or e.

As alluded to previously, NFC-capable display devices may alter the“normal” establishment of communications. For example, a user may wishto have analyte sensor system 104 transmit sensor information prior to ascheduled transmission. This can be due to the user/host 102 feeling theonset of a hypoglycemic condition, or the user may wish to have abacklog of sensor data transmitted in a “data dump” to one of displaydevices 120. In operation, a user can invoke directed advertisingthrough the use of NFC-capable display device, e.g., display device 120c. As previously discussed, directed advertising allows a displaydevice, e.g., display device 120 c to “tap” display device 120 c onanalyte sensor system 104 (e.g., bringing the display devicesubstantially close to the analyst sensor system to effectuate an NFCcommunication) thereby instructing CGM processor 506 to wake up (wheresensor electronics module 106 may have a separate NFC transceiver (notshown)). CGM processor 506 may then instruct radio 508 to beginadvertising to display device 120 c or to another one of displaydevices, e.g., in accordance with an advertising order based on thewhitelist, for example, a most recent connection, or some otherpreferred display device. CGM processor 506 may also access historicalEGV data (discussed further below) and determine that the user/host 102is trending towards a potential hypoglycemic condition in which case,CGM processor 506 may attempt to establish a wireless connection withdisplay device 120 a and may further increase the advertising durationA_(dr) in order to increase the chances of establishing a wirelesscommunication session. Alternatively still, upon the user invokingdirected advertising, analyte sensor system 104 may access the whitelistto determine which of display devices 120 populates the initialposition, which in some embodiments can indicate the “preferred” or“primary” display device. Analyte sensor system 104 would then attemptto establish a wireless communication session with thatpreferred/primary display device.

It may be beneficial to have display devices optimal for a particularscenario present/populating the whitelist so that a wirelesscommunication session can be established quickly. Thus, in accordancewith some embodiments the whitelist is updated in accordance withcondition of the whitelist itself. That is, the presence of certaindisplay devices having certain capabilities can be used to initiate,e.g., the removal of other display devices not compliant with thosecapabilities. For example, the existence of an NFC-capable device, e.g.,display device 120 c, in the whitelist may prompt the removal of anon-NFC-capable display device, e.g., display device 120 d because auser may rely on the NFC capabilities of display device 120 c to obtainEGV data, or alternatively, to pair/initiate the wireless communicationsession, thereby disqualifying display device 120 d.

FIG. 8D illustrates example processes performed for updating thewhitelist in accordance with this embodiment. At operation 801, a wakeevent is received, the wake event being initiated by an NFC-capabledevice. That is, display device 120 c, which may be a smart phone, canbe tapped on analyte sensor system 104 to initiate a wake up signal tobe sent from AFE 500 (FIG. 5) to CGM processor 506. Similar to FIG. 8A,CGM processor 506 can receive sensor information at operation 802, andanalyte data is calculated and stored at operation 804. At operation 806f, whitelist conditions are determined. As described above, in thisexample, at least one NFC-capable device is populating the whitelist,e.g., display device 120 c, along with a non-NFC-capable device, e.g.,display device 120 d. At operation 807, the non-NFC-capable displaydevice is removed from the whitelist. At operation 809, a wirelesscommunication session is initiated with the at least one NFC-capabledisplay device. Thus, an NFC process can be used to effectuate thewireless communication session with display device 120 c, or withanother NFC-capable device, e.g., display device 120 b. At operation812, the analyte data is transmitted to one of display device 120 c ordisplay device 120 b. In this way, time and resources need not be wastedadvertising to display device 120 d. It should be noted that althoughthis embodiment is disclosed in the context of removing anon-NFC-capable device, other conditions and actions regarding devicecapabilities and whitelist updates, whether display devices are added,removed, re-ordered, etc. are contemplated. In some embodiments, displaydevices, for example, display device 120 c may include both NFC andnon-NFC communication protocol (e.g., a BLE communication protocol). Assuch, when it is determined that the display device 120 c has NFCcapability, device 120 c may also be taken out of the whitelist, so thatanalyte sensor device 104 communicates analyte sensor data to thedisplay device 120 c only via NFC communication, rather than via BLEcommunication protocol.

As alluded to previously, adhering to set advertising and/or connectionparameters may result in wasting radio resources as well as result inless reliable communications. In some embodiments, historicalcommunication conditions can be determined or analyzed in order tooptimize the advertising duration. For example, the advertising andconnection software can be configured to operate using an algorithm thatvaries the advertising duration based upon historical statistics orinformation regarding time-til-connection periods. That is, the CGMprocessor 506 can instruct the radio 508 to progressively lessen theadvertising duration by some predetermined amount until a measuredconnection rate for one or more display devices drops below apredetermined connection rate or percentage threshold. Alternatively,the advertising duration can be progressively decreased depending thelack of a connection, e.g., if a display device, e.g., display device120 c (having an advertising duration A_(dp) of X_(p) seconds) has notconnected to the analyte sensor system 104 within the last 5 minutes,the advertising duration A_(dp) for display device 120 c will be reducedto X_(p)′ seconds from X_(p) seconds, and so on. The lack of connectionmay suggest the absence of display device 120 c, and battery power canbe conserved by stepping down the advertising duration A_(dp) oreventually stopping the transmission of advertising beacons 700altogether, and, e.g., advertising to another display device. If,however, display device 120 c comes back into range of analyte sensorsystem 104, e.g., prior to the end of the transmission of advertisingbeacons 700, or if the user initiates directed advertising to displaydevice 120 c, the algorithm can reinstate the advertising durationA_(dp) for display device 120 c (either in full, e.g., X_(p) seconds, orin a progressively increasing manner based upon additional, subsequentwireless communication sessions being established).

The algorithm may alternatively or additionally predictively estimatewhat display devices are likely to be within range of the analyte sensorsystem, and tailor the advertising duration(s) to those display devices.In particular, the algorithm may instruct CGM processor 506 to accessmemory 318, for example, to analyze historical connection statistics.Based on the historical connection statistics, the algorithm maygenerate an advertising profile that optimizes the likelihood ofconnection to one or more display devices 120. Historical connectionstatistics can include, e.g., the times of day that a particular displaydevice connects to analyte sensor system 104. Historical connectionstatistics can also include, as previously discussed, previousadvertising interval/duration budgets as well as historicaltime-til-connection durations, C_(d).

For example, based on the historical connection statistics, it may bedetermined that from the hours of 6 pm to 6 am, display device 120 cdoes not usually respond to advertising beacons 700, whereas displaydevice 120 a does. Accordingly, radio 508 can be instructed to onlyadvertise (using advertising beacons 702) to display device 120 a fromthe hours of 6 pm to 6 am using the appropriate advertising durationA_(dr) for display device 120 a. As another example, the algorithm maydetermine the number of recent connections that occur for particulardisplay devices, the amount of missed advertising packets associatedwith particular display devices, etc. and instruct radio 508 toadvertise to those display devices (using the appropriate advertisingduration) having successfully connected during some recent time period,and to skip advertising to those display devices associated with missedadvertising packets.

Still other embodiments may operate based on an analysis of EGV and/orraw sensor data. For example, the CGM processor 506 may alteradvertising duration and/or advertising intervals for one or moredisplay devices according to a user's state based on the EGV and/or rawsensor data. That is, if EGV data indicates that the user is goinghypoglycemic, the advertising duration for one or more display devicescan be increased and/or the advertising interval can be shortened inorder to reduce the chance that advertising beacons will be missed. Yet,during non-critical periods, e.g., when the EGV data indicates that theuser is in a healthy state, the same advertising duration can beshortened and/or the same advertising interval can be increased, asproviding the EGV data is less critical. Thus, the establishment of awireless communication session can be delayed.

FIG. 8E is a flow chart illustrating example processes performed inaccordance with the above example scenario, and will be described withreference to previously described FIGS. 1, 6, and 7 for ease ofunderstanding.

CGM processor 506 may calculate analyte data and store that calculatedanalyte data (operation 804 and process 604 of FIG. 6). It should beunderstood that operations 800 and 802 (illustrated in FIG. 8A) may havealready been performed, i.e., a wake event may have already beenreceived, and CGM processor 506 may have already received sensorinformation from analyte sensor system 104, thereby allowing CGMprocessor 506 to calculate the analyte data. In accordance with one ormore algorithms utilized in controlling CGM processor 506, CGM processor506 may be instructed to determine one or more communication conditions(operation 806). In this example, CGM processor 506 may be instructed toanalyte EGV data (operation 806 c) which includes historical EGV data.Thus, CMG processor 506 may access its database and review somepredetermined number of (or for some predetermined amount of time)calculated EGV values to determine a recent trend of analyte (in thiscase, glucose) measurements. If the observed trend of analytemeasurements indicates that the user (e.g., host 102 of FIG. 1) may befalling into a hypoglycemic condition, CGM processor 506 can determinethe existence of an alarm condition (operation 806 d). As such, CGMprocessor 506 can start advertising (operation 808 and process 606 ofFIG. 6) sooner than may be “normally” configured with radio 508,prompting radio 508 to begin advertising to one or more display devices120. Moreover, the advertising interval A_(ip) (FIG. 7) for one or moreof display devices 120, e.g., display device 120 c, may be shortened,resulting in more frequent advertising beacons 702 being transmitted inan attempt to increase the chance of connection. Alternatively or inaddition, the advertising duration A_(dr) can be increased for displaydevice 120 a. For example, given that display 120 a, a dedicated CGMdisplay device, may have the greatest chance for connection to radio 508of sensor electronics module 106, the advertising duration A_(dr) can beincreased for that specific display device. It should be noted that therequisite connections/wireless communications sessions/transfer of EGVdata can occur as illustrated in FIG. 8A.

Returning to FIG. 7, it can be appreciated that the advertisingduration, A_(d), can be altered depending on the transmission protocolcurrently being/to be utilized. That is, certain transmission protocolsmay have a smaller “operative distance” between peripheral andcentral(s). For example, when utilizing NFC, CGM processor 506 cangenerate/calculate advertising durations for one or more of displaydevices 120 that have been shortened based on the assumption that theone or more display devices 120 will be close to analyte sensor system104 and will not likely require extended advertising durations.Additionally, the advertising durations of non-NFC display devices maybe negated when the wireless communication session initiation/pairing isaccomplished using NFC.

In other embodiments, a user's temperature and/or predicted ordetermined activity level or lack thereof can be used as a conditionupon which advertising is based. For example, analyte sensor system 104may employ one or more accelerometers or other sensors capable ofdetermining the activity level of a user/host 102. Upon CGM processor506 determining, based on feedback from analyte sensor system 104 that auser is assumed to be sleeping, e.g., based on sensed lack of movementor time of day, advertising durations A_(d) for one or more displaydevices 120 may be reduced unless a critical or alarm condition issensed. Alternatively, CGM processor 506 may determine, based onfeedback from analyte sensor system 104 that a user/host 102 is assumedto be engaged in some activity, e.g., running. In this case, CGMprocessor 506 can instruct radio 508 to advertise only to a displaydevice that the user is likely to have on his/her person, such as asmart watch, i.e., display device 120 b, rather than another displaydevice, such as a tablet PC, i.e., display device 120 d. Thedetermination regarding which display device(s) the user is likely tohave on his/her person can be made based on which display device(s) arepopulating the whitelist, one or more display device type identifiers,historical information, time of day information, etc. (discussedpreviously).

It should be noted that the existence or absence of alerts/alarmconditions or triggers, approaching an alert/alarm condition, EGV/rawsensor trending data or predictions can be leveraged in the same manner.For example, EGV or raw sensor data can be analyzed by CGM processor 506to determine whether a user is trending towards, e.g., a hypoglycemiccondition, and/or predictive algorithms can be used to predict a user'scurrent or future state, and advertising duration A_(d) and/oradvertising interval A_(d) variables can be adjusted commensurate withthat data/prediction(s). It should also be noted that the amount ofpower used for transmitting each advertising beacon can be adjustedbased on the same or similar communication conditions used to adjust theadvertising duration and/or interval. For example, if display device 120b, i.e., a smart watch, connects to analyte sensor system 104, CGMprocessor 506 may instruct radio 508 to reduce the power used totransmit advertising beacons inasmuch as it may be assumed that displaydevice 120 b will be on the user's body/wrist, near sensor electronicsmodule 106. Thus, less power is likely needed for the advertisementbeacons. It should be noted that the transmission power forcommunicating sensor information/analyte data may also be decreased.

Relying solely on the sensor electronics module 106 of analyte sensorsystem 104 to effectuate data transfer to one or more of display devices120 can be taxing from a battery power perspective. In accordance withother embodiments, networking techniques or architectures can beleveraged, e.g., mesh networking, to reduce advertising as well asconnection frequency. For example, a first display device, e.g., displaydevice 120 c, may connect to analyte sensor system 104. Thereafter,display device 120 c may advertise to one or more additional devices,e.g., display devices 120 b and 120 d, so analyte sensor system 104 neednot have to deplete its own battery power to transmit advertisingbeacons, connect to other display devices, etc. Moreover, depending onthe type of display devices present, analyte sensor system 104 may notbe an optimal connection/communication candidate. Accordingly, andagain, networking or “direct” communications between display devices mayresult in better connection reliability. For example, display devices120 b and 120 c may be optimized for data transfer therebetween, suchthat data communications between display devices 120 b and 120 c aremore reliable than between, e.g., display device 120 b and analytesensor system 104.

In some scenarios, it may be beneficial to allow a user to control whichdisplay device(s) 120 connect to analyte sensor system 104 to receivesensor data. Thus, in accordance with some embodiments, the whitelistcan be user-modifiable or updatable. In particular, a user may specify adesired display device to connect to by accessing the whitelist whichcan be stored, e.g., in memory 318, and interacting with the whitelistthrough a user interface provided on one or more of display devices 120.In this way, radio 508 need not transmit advertising beacons to adisplay device that the user does not intend to rely on. As describedpreviously, a whitelist may be a list of display devices reflectingthose display devices that have successfully been paired or bonded withthe sensor electronics module 106.

FIG. 8F is a flow chart illustrating example processes performed inaccordance with the above-described scenario. Like FIG. 8A, a wake eventis received at operation 800, sensor information is received, e.g., byCGM processor 506, at operation 802, and at operation 804, analyte datacan be calculated and stored by CGM processor 506 based on the receivedsensor information. At operation 806, whitelist conditions aredetermined, one aspect of communication conditions, as discussed above.As alluded to above, the whitelist can be configured/updated by the usereither directly or indirectly (e.g., via manipulation of another displaydevice list that is different than the whitelist). Thus, at operation820, the whitelist is accessed, e.g., by CGM processor 506 vis-à-vis aninstruction by a user interface providing user control over thewhitelist. At operation 822, the whitelist is configured in accordancewith the user's display device preferences. Returning to operation 808,a transceiver, e.g., radio 508, can be instructed by CGM processor 506to advertise to at least a first display device in accordance with oneor more communication variables based upon the one or more communicationconditions. In this instance, the advertising is performed based on thewhitelist configured/updated by the user. If that specified displaydevice does not connect, the radio 508 can be instructed to return to adefault or previous advertising scheme (with the appropriate advertisingduration/time/power) at operation 813. For example, the user may specifythat display device 120 b is to be used for the establishment of awireless communication session and transfer of EGV data from some periodof time. This may occur, for example, if the user is exercising andwishes to receive sensor information on a convenient display device, inthis case, display device 120 b, a smart watch. However, if the userforgets to wear display device 120 b, after some threshold time offailing to establish a wireless communication session with displaydevice 120 b, radio 508 can be instructed to begin transmittingadvertising beacons in accordance with a default whitelist population.At operation 814, connection to a second display device is established(based upon the default or previous advertising scheme).

In still other embodiments, the order in which display devices connectto the analyte sensor system 104 may also be leveraged to save batterypower as well as increase connection speed and connection reliability.For example, if EGV data suggests that a user is nearing a hypoglycemicstate, radio 508 may transmit advertising beacons 702 to a lastconnected display device or a default display device, such as displaydevice 120 a, a dedicated CGM display device, so that the likelihood ofconnection is heightened while also potentially reducing wasted batterypower by advertising to a display device that is unlikely to connect.Moreover, advertising can be adapted such that advertisement beacons areonly sent to a particular display device depending on which displaydevice(s) has/has not connected, e.g., advertisements to display device120 b associated with a display device 120 c may be transmitted only ifdisplay device 120 c is/has connected to radio 508.

In accordance with another embodiment, the whitelist may be used toforce a connection with a preferred display device, e.g., display device120 b (in the previously described example) and then the aforementionedmesh networking scheme can be leveraged such that the preferred displaydevice, once connected, can assume the role of advertising to additionaldisplay devices. That is, and in this instance, display device 120 b,may connect to analyte sensor system 104. Thereafter, display device 120b may advertise to one or more additional devices, e.g., display devices120 a and d, so analyte sensor system 104 need not have to deplete itsown battery power to transmit advertising beacons, connect to otherdisplay devices, etc.

FIG. 8G is a flow chart illustrating example processes performed inaccordance with the above example scenario, and will be described withreference to previously described FIGS. 1, 6, and 7 for ease ofunderstanding. Like the flow chart of FIG. 8E, CGM processor 506 maycalculate an EGV value and store that calculated EGV value (operation804 and process 604 of FIG. 6). It should be understood that operations800 and 802 (illustrated in FIG. 8A) may have already been performed. Inaccordance with one or more algorithms utilized in controlling CGMprocessor 506, CGM processor 506 may be instructed to determine one ormore communication conditions (operation 806). In this example, CGMprocessor 506 may be instructed to analyte EGV data (operation 806 c)which includes historical EGV data. Thus CMG processor 506 may accessits database and review some predetermined number (or for somepredetermined amount of time) calculated EGV values to determine arecent trend of analyte (in this case, glucose) measurements. If theobserved trend of analyte measurements indicates that the user (e.g.,host 102 of FIG. 1) may be falling into a hypoglycemic condition, CGMprocessor 506 can determine the existence of an alarm condition(operation 806 d). However, in this example, display device variablesare taken into consideration, where the order of display deviceconnection (determined via the whitelist conditions at operation 806 f)may be the following: display device 120 c connected first; displaydevice 120 a connected second. Thus, per the above scenario, radio 508is instructed to transmit advertising beacons 702 (FIG. 7) to displaydevice 120 a, the last connected display device (operation 808). Displaydevice 120 a may then connect to analyte sensor system 104 (inparticular, radio 508) and a wireless communication session can beestablished (operation 810). Moreover, the role of the display devicemay also be considered. In this scenario, display device 120 a isconfigured to act as an advertising entity. Thus, display device 120 amay continue with advertising to display device 120 c and connectthereto (operation 810). EGV data my then be transmitted per operation812 of FIG. 8A and so on.

Intelligent Communication

While intelligent advertising schemes or techniques can be utilized toconserve battery power, actual communications between analyte sensorsystem 104 and one or more display devices 120 can also be made moreefficient to also reduce the drain on the sensor electronics module'sbattery.

To achieve efficient communications, some embodiments may adjust thefrequency with which EGV data is transmitted (illustrated as, e.g.,first data communication 416, second data communication 424, etc.),i.e., the update frequency. As described above, with regard to actual,trending, and/or predicted data, alerts/alert boundaries, as well asalarms/alarm conditions, the frequency with which data is sent can vary,i.e., less frequently when the user is in a clinically “safe” zone andmore frequently when the user is in or is nearing a potentiallyclinically unsafe condition, e.g., a hypoglycemic state. In accordancewith one embodiment, EGV data is only transmitted upon the satisfactionof an alert condition, thereby significantly reducing the battery powerthat would be conventionally consumed if such data were being sent morefrequently.

A user may also be allowed to set the update frequency (discussed above)to conserve battery power. For example, the user may be allowed tospecify that if a last EGV calculation is within some range (e.g.,percentage) of a median bound, then a particular update frequency can beemployed. Similar to updating the whitelist described above, a userinterface may be provided in one or more display devices 120 (ordirectly on analyte sensor system 104, e.g., on sensor electronicsmodule 106). The user interface can be accessed by the user, where theuser interface provides a mechanism for indicating an EGV threshold thatis used as a basis for update frequency. However, in the event of arecent calibration, a recent dose of insulin (e.g., from display device120 e, a medicament delivery device), or consumption of carbs,communications can be established immediately and/or the updatefrequency can be increased.

In order to increase battery life and/or connection reliability, it maybe beneficial to allow transmission modes to be specified or controlledto comport with certain communication conditions. For example, two-waycommunications which require power to be supplied to, e.g., sensorelectronics module during transmission and receipt of data, may beunnecessary in certain scenarios. Thus, a user's condition may be usedas a basis for determining a mode of transmission. In particular, someembodiments may allow CGM processor 506 to base a mode of transmissionon sensor or EGV data, where one-way or two-way communications can beeffectuated depending on the data received/calculated by the CGMprocessor. For example, if a user's is not in a critical state,transmissions can occur using, e.g., a one-way burst transmission (asdescribed above), but if the user enters or nears a critical state, thetransmission mode may switch to two-way communications or othercommunication protocols, where the user can request EGV data on-demand(e.g., via NFC). Still other circumstances where a transmission mode canbe adapted include times when analyte sensor system 104 is undergoingcalibration. As another example, a transmission mode can be adjusted inresponse to a situation where a wireless communications session cannotbe established over one or more update periods resulting in missedsensor information that should be backfilled.

FIG. 8H is a flow chart illustrating example processes performed inaccordance with the above example scenario, and will be described withreference to previously described FIGS. 1, 6, and 7 for ease ofunderstanding. CGM processor 506 may calculate an EGV value and storethat calculated EGV value (operation 804 and process 604 of FIG. 6). Itshould be understood that operations 800 and 802 (illustrated in FIG.8A) may have already been performed. In accordance with one or morealgorithms utilized in controlling CGM processor 506, CGM processor 506may be instructed to determine one or more communication conditions(operation 806). In accordance with one example, CGM processor 506 maybe instructed to analyze EGV data (operation 806 c) which includeshistorical EGV data. Thus CGM processor 506 may access its database andreview some predetermined number (or for some predetermined amount oftime) calculated EGV values to determine a recent trend of analyte (inthis case, glucose) measurements. If the observed trend of analytemeasurements indicates that the user (e.g., host 102 of FIG. 1) may befalling into a hypoglycemic condition, CGM processor 506 can determinethe existence of an alarm condition (operation 806 d). Based on thisdetermination that an alarm condition exists, the type of communicationswill be set to 2-way communications or a different wireless protocol maybe implemented, and advertising can commence (operation 808).Accordingly, a display device, e.g., display device 120 c, connects toanalyte sensor system 104 and establishes a wireless communicationsession (operation 810). Moreover, the EGV data is transmitted atoperation 812. If desired, the user can request EGV data on-demand (via,e.g., NFC-directed advertising), and operation returns to operation 800.However, if it is determined that an alarm condition does not exist, thetype of communications will be set to 1-way communications, in whichcase, the advertising beacons can be configured to include EGV trenddata, for example, and a wireless communications session need not beestablished (operation 808).

Further to the above, data packet formatting can be affected as well,e.g., one-way transmission of data can occur with unencrypted data,while two-way communication of data utilizes encrypted data, andvice-versa. Moreover, update alerts can be transmitted to one or more(secondary) display devices, such as display device 120 b and/or displaydevice 120 c, instructing them to establish communications with a(primary) display device, such as display device 120 a, to transmit astatus update. Additionally still, previously stored/analyzed raw sensordata and/or EGV data can be used to predict possible user states,determine patterns associated with the user's states, e.g., throughoutthe day, learn the user's behavior that may impact his/her state, etc.Such data may then be utilized to determine what or when the nexttransmission of data should occur. Hence, the aforementioned mode oftransmission and/or frequency of transmission can be adaptedaccordingly.

Additionally, the state of the analyte sensor system 104 can be acondition upon which communications may be altered. For example, asalluded to previously, a communication command may be used to ensureradio 508 does not exceed a predefined communication window. That is,and referring back to processes 612 of FIG. 6, a CGM transmit commandcomprises a response to a connection request for performing the reverseoperations of the CGM receive command, i.e., it takes the payload andsends it to the radio stack to be transmitted on the RF link. A stopcommunication command may be used to ensure radio 508 does not exceed apredefined “communication window,” which in some embodiments is, e.g.,30 seconds, since RF noise can affect AFE sensor measurements. This stopcommand accordingly can be sent, e.g., 26 seconds after the startcommunication command is sent. Moreover, the presence of excessivesignal noise may suggest that communications with a particular displaydevice should be stopped, and the transmission of data should continuewith an alternative display device.

Direct transmission of analyte data can be implemented in an encryptedmanner in/on an advertising beacon. That is, advertising beaconscontaining encrypted analyte data can be used to directly communicatethose measured analyte values, e.g., glucose values, withoutestablishing a two-way communication protocol. A display device can beallowed to select source information based on the establishment or lackof another connection. For example, in some embodiments, connection of afirst display device can be determined, e.g., a wireless connectionbetween analyte sensor system 104 and display device 120 c. Datatransmission of sensor information can be effectuated directly fromdisplay device 120 c to a second display device, e.g., display device120 b. Otherwise, data transmission can occur between the analyte sensorsystem 104 and display device 120 b. Additionally, an encryption schemecan be established using two-way communication pursuant to an initialtransmission of data, e.g., a static display device encryption key canbe used to avoid setting up two-way communication for each transmission.

The formatting of data packets may also include using one or more datacompression techniques. In accordance with some embodiments, analogwaveform compression techniques such as Fourier transformation, etc. canbe used to compress the EGV data resulting in much smallertransmissions, which in turn results in reduced battery use. Forexample, and referring back to FIG. 4, first and second data connections416 and 424 can be shortened in duration. In accordance with otherembodiments, the transmission of data can be reduced by, e.g., nottransmitting backfill data, calibration data, etc. unless needed. Forexample, if a user's state is not critical or an analyzed data trendsuggests that the user's state is safely within a “cone ofpossibilities,” backfill data need not be transmitted from analytesensor system 104 to one or more of display devices 120. In still otherembodiments, an initial data transmission (or an advertising beacon,e.g., advertising beacons 700 of FIG. 7) can include informationindicating to one or more display devices, e.g., display device 120 c,what type of data will be forthcoming in a subsequent transmission. Inthis way, a user can refuse or deny backfill data if it is not needed,or display device 120 c may be able to determine on its own that suchdata need not be received.

A scenario in which this may arise is when the user may have forgottenone or more of his/her display devices 120, and thus, an extended periodof time goes by in which analyte sensor system 104 does not connect toany of the display devices 120. Upon the user, e.g., returning tohis/her home, and at least one of display devices 120 responding to anadvertising beacon, e.g., display device 120 c responding to advertisingbeacons 700 (also illustrated as authentication/channelestablishment/data connection establishment 414 of FIG. 4), the user candecide whether or not to receive backfill sensor information. That is,if the user is sufficiently certain that he/she is not approaching or inpotentially adverse condition, he/she can refuse the backfill sensorinformation. Alternatively, display device 120 c may receive an initialEGV that suggests that the user is in a stable condition, in which case,display device 120 c may determine (according to a predictive algorithm)that backfill sensor information is not needed.

In accordance with some embodiments, alternative or additionalcommunication protocols/methods can be leveraged to reduce batteryconsumption, e.g., NFC. For example, a connected display device, e.g.,display device 120 b, may only receive communications from the analytesensor system 104 that triggers a notification to be presented to theuser or an indicator to light and/or emit sound instructing the user toswipe or touch display device 120 b or another display device, e.g., 120c, to the analyte system sensor 104 in order to receive datatransmission via NFC, rather than consuming battery power withconventional wireless communication of the data. Moreover, out-of-bandNFC pairing of a display device, e.g., display device 120 c, to theanalyte sensor system 104 can be used, where a user need only tapdisplay device 120 c to the analyte sensor system 104 to connect to andinitiate data transmission from analyte sensor system 104. This negatesthe need to wait for advertising beacons (described previously) and theneed to send a command request (illustrated as 412 in FIG. 4. and 614 inFIG. 6, respectively). The whitelist as well, may be populated and/orupdated in a similar manner to achieve “user-selective” pairing, wherethe exchange of keys and bonding information, as well as the passing ofauthentication/authorization information can also occur via NFC. Itshould be noted that sensor electronics module 106 (described above) canbe configured to include an NFC transceiver in addition to the radio508.

As with intelligent advertising, intelligent communication can alsoutilize alternative networking techniques, e.g., mesh, peer-to-peer, orcloud networking. Similar to allowing a display device, such as displaydevice 120 c, to advertise to additional display devices, such asdisplay device 120 b, display device 120 c can also be utilized toconnect to and transmit EGV data to display device 120 b, therebylimiting the amount of connections to/transmissions from the analytesensor system 104. The transmitting display device, in this case displaydevice 120 c, can be used to perform the necessary setup/handshakingbetween the additional display devices, in this case display device 120b, e.g., exchange of encryption keys, determining display device type,etc.

FIG. 9 illustrates an example continuous analyte monitoring system 900(which may be an embodiment of the continuous analyte monitoring system100 of FIG. 1) and a plurality of alternative networking optionscontemplated in accordance with various embodiments. In accordance withone embodiment described above, display device 120 c and be used toadvertise (transmit advertising beacons) to additional display devices,in this example, display device 120 b. Crosslink signals 116 a and b canbe used to effectuate the aforementioned encryption key exchange,setup/handshaking, display device type determination, etc.

In some embodiments, such alternative networking techniques may be usedto backfill data on one or more display devices. For example, andreferring again to FIG. 9, a primary display device, such as displaydevice 120 a, may have up-to-date and complete EGV data, where displaydevice 120 a can then be used to transmit backfill data to one or moresecondary display devices if needed, rather than relying on the analytesensor system 104 to transmit backfill data, again, reducing batterypower consumption on the analyte sensor system 104. FIG. 9 illustratesthat display device 120 a may obtain EGV data and/or engage in wirelesscommunications with analyte sensor system 104 using uplink signals 114and downlink signals 112. In the case of cloud networking, secondarydisplay devices, such as display device 120 d, may receive requisitedata that has been uploaded to the cloud network (network 930 which caninclude a remote server 932 and/or associated database 934) via theprimary display device, display device 120 a again reducing the strainon the analyte sensor system 104. In some embodiments, the entityproviding analyte sensor system 104 may maintain server 932 and database934. Further still, the analyte system sensor 104 and/or display device120 a, for example, can be made aware of secondary display devices thatmay require data, in which case, analyte sensor system 104 may thenengage in selective data transmission rather than broadcasttransmission. This may be the case with display device 120 e, forexample.

It should be noted that a plurality of methods and/or techniques may beused to effectuate the embodiments disclosed in the present disclosure.That is, the above-described communication conditions and adjustment ofcommunication variables can be rules or instructions (e.g., in the formof a matrix or matrices) used by one or more algorithms that can controloperation of the analyte sensor system 104, in particular, CGM processor506 and/or the transceiver, e.g., radio 508, NFC transceiver, etc.Moreover, the analyte sensor system 104 can learn from itself and“create” such rules. It should also be noted that various combinationsof the above-mentioned embodiments/operational scenarios can be combinedin different ways to achieve one or more desired operationalcharacteristics in a continuous analyte measurement system. Althoughvarious embodiments have been described in the context of continuousanalyte measurement, e.g., continuous glucose monitoring, the variousembodiments can be adapted for use in other context as well, e.g., formonitoring vital signals.

As used herein, the term module might describe a given unit offunctionality that can be performed in accordance with one or moreembodiments of the present application. As used herein, a module mightbe implemented utilizing any form of hardware, software, or acombination thereof. For example, one or more processors, controllers,ASICs, PLAs, PALs, CPLDs, FPGAs, logical components, software routinesor other mechanisms might be implemented to make up a module. Themodules, circuitry, processors, etc. may be affixed to a printed circuitboard (PCB), or the like, and may take a variety of forms. Inimplementation, the various modules described herein might beimplemented as discrete modules or the functions and features describedcan be shared in part or in total among one or more modules. In otherwords, as would be apparent to one of ordinary skill in the art afterreading this description, the various features and functionalitydescribed herein may be implemented in any given application and can beimplemented in one or more separate or shared modules in variouscombinations and permutations. Even though various features or elementsof functionality may be individually described or claimed as separatemodules, one of ordinary skill in the art will understand that thesefeatures and functionality can be shared among one or more commonsoftware and hardware elements, and such description shall not requireor imply that separate hardware or software components are used toimplement such features or functionality.

Where components or modules of the application are implemented in wholeor in part using software, in one embodiment, these software elementscan be implemented to operate with a computing or processing modulecapable of carrying out the functionality described with respectthereto. One such example computing module is shown in FIG. 10 which maybe used to implement various features of the system and methodsdisclosed herein. Various embodiments are described in terms of thisexample computing module 1000. After reading this description, it willbecome apparent to a person skilled in the relevant art how to implementthe application using other computing modules or architectures.

Referring now to FIG. 10, computing module 1000 may represent, forexample, computing or processing capabilities found within aself-adjusting display, desktop, laptop, notebook, and tablet computers;hand-held computing devices (tablets, PDA's, smart phones, cell phones,palmtops, etc.); workstations or other devices with displays; servers;or any other type of special-purpose or general-purpose computingdevices as may be desirable or appropriate for a given application orenvironment. For example, computing module 1000 may be one embodiment ofone of display devices 120, sensor electronics module 106, etc.Computing module 1000 might also represent computing capabilitiesembedded within or otherwise available to a given device. For example, acomputing module might be found in other electronic devices such as, forexample, portable computing devices, and other electronic devices thatmight include some form of processing capability.

Computing module 1000 might include, for example, one or moreprocessors, controllers, control modules, or other processing devices,such as a processor 1004. Processor 1004 might be implemented using ageneral-purpose or special-purpose processing engine such as, forexample, a microprocessor, controller, or other control logic. In theillustrated example, processor 1004 is connected to a bus 1002, althoughany communication medium can be used to facilitate interaction withother components of computing module 1000 or to communicate externally.

Computing module 1000 might also include one or more memory modules,simply referred to herein as main memory 1008. For example, preferablyrandom access memory (RAM) or other dynamic memory might be used forstoring information and instructions to be executed by processor 1004.Main memory 1008 might also be used for storing temporary variables orother intermediate information during execution of instructions to beexecuted by processor 1004. Computing module 1000 might likewise includea read only memory (“ROM”) or other static storage device coupled to bus1002 for storing static information and instructions for processor 1004.

The computing module 1000 might also include one or more various formsof information storage mechanism 1010, which might include, for example,a media drive 1012 and a storage unit interface 1020. The media drive1012 might include a drive or other mechanism to support fixed orremovable storage media 1014. For example, a hard disk drive, a solidstate drive, a magnetic tape drive, an optical disk drive, a compactdisc (CD) or digital video disc (DVD) drive (R or RW), or otherremovable or fixed media drive might be provided. Accordingly, storagemedia 1014 might include, for example, a hard disk, an integratedcircuit assembly, magnetic tape, cartridge, optical disk, a CD or DVD,or other fixed or removable medium that is read by, written to oraccessed by media drive 1012. As these examples illustrate, the storagemedia 1014 can include a computer usable storage medium having storedtherein computer software or data.

In alternative embodiments, information storage mechanism 1010 mightinclude other similar instrumentalities for allowing computer programsor other instructions or data to be loaded into computing module 1000.Such instrumentalities might include, for example, a fixed or removablestorage unit 1022 and an interface 1020. Examples of such storage units1022 and interfaces 1020 can include a program cartridge and cartridgeinterface, a removable memory (for example, a flash memory or otherremovable memory module) and memory slot, a PCMCIA slot and card, andother fixed or removable storage units 1022 and interfaces 1020 thatallow software and data to be transferred from the storage unit 1022 tocomputing module 1000.

Computing module 1000 might also include a communications interface1024. Communications interface 1024 might be used to allow software anddata to be transferred between computing module 1000 and externaldevices. Examples of communications interface 1024 might include a modemor softmodem, a network interface (such as an Ethernet, networkinterface card, WiMedia, IEEE 802.XX or other interface), acommunications port (such as for example, a USB port, IR port, RS232port Bluetooth® interface, Bluetooth Low Energy, or other port), orother communications interface. Software and data transferred viacommunications interface 1024 might typically be carried on signals,which can be electronic, electromagnetic (which includes optical) orother signals capable of being exchanged by a given communicationsinterface 1024. These signals might be provided to communicationsinterface 1024 via a channel 1028. This channel 1028 might carry signalsand might be implemented using a wired or wireless communication medium.Some examples of a channel might include a phone line, a cellular link,an RF link, an optical link, a network interface, a local or wide areanetwork, and other wired or wireless communications channels.

In this document, the terms “computer program medium” and “computerusable medium” are used to generally refer to transitory ornon-transitory media such as, for example, memory 1008, storage unit1020, media 1014, and channel 1028. These and other various forms ofcomputer program media or computer usable media may be involved incarrying one or more sequences of one or more instructions to aprocessing device for execution. Such instructions embodied on themedium, are generally referred to as “computer program code” or a“computer program product” (which may be grouped in the form of computerprograms or other groupings). When executed, such instructions mightenable the computing module 1000 to perform features or functions of thepresent application as discussed herein.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, such illustration and descriptionare to be considered illustrative or exemplary and not restrictive. Thedisclosure is not limited to the disclosed embodiments. Variations tothe disclosed embodiments can be understood and effected by thoseskilled in the art in practicing the claimed disclosure, from a study ofthe drawings, the disclosure and the appended claims.

All references cited herein are incorporated herein by reference intheir entirety. To the extent publications and patents or patentapplications incorporated by reference contradict the disclosurecontained in the specification, the specification is intended tosupersede and/or take precedence over any such contradictory material.

Unless otherwise defined, all terms (including technical and scientificterms) are to be given their ordinary and customary meaning to a personof ordinary skill in the art, and are not to be limited to a special orcustomized meaning unless expressly so defined herein. It should benoted that the use of particular terminology when describing certainfeatures or aspects of the disclosure should not be taken to imply thatthe terminology is being re-defined herein to be restricted to includeany specific characteristics of the features or aspects of thedisclosure with which that terminology is associated. Terms and phrasesused in this application, and variations thereof, especially in theappended claims, unless otherwise expressly stated, should be construedas open ended as opposed to limiting. As examples of the foregoing, theterm ‘including’ should be read to mean ‘including, without limitation,’‘including but not limited to,’ or the like; the term ‘comprising’ asused herein is synonymous with ‘including,’ ‘containing,’ or‘characterized by,’ and is inclusive or open-ended and does not excludeadditional, unrecited elements or method steps; the term ‘having’ shouldbe interpreted as ‘having at least;’ the term ‘includes’ should beinterpreted as ‘includes but is not limited to;’ the term ‘example’ isused to provide exemplary instances of the item in discussion, not anexhaustive or limiting list thereof; adjectives such as ‘known’,‘normal’, ‘standard’, and terms of similar meaning should not beconstrued as limiting the item described to a given time period or to anitem available as of a given time, but instead should be read toencompass known, normal, or standard technologies that may be availableor known now or at any time in the future; and use of terms like‘preferably,’ ‘preferred,’ ‘desired,’ or ‘desirable,’ and words ofsimilar meaning should not be understood as implying that certainfeatures are critical, essential, or even important to the structure orfunction of the present disclosure, but instead as merely intended tohighlight alternative or additional features that may or may not beutilized in a particular embodiment. Likewise, a group of items linkedwith the conjunction ‘and’ should not be read as requiring that each andevery one of those items be present in the grouping, but rather shouldbe read as ‘and/or’ unless expressly stated otherwise. Similarly, agroup of items linked with the conjunction ‘or’ should not be read asrequiring mutual exclusivity among that group, but rather should be readas ‘and/or’ unless expressly stated otherwise.

Where a range of values is provided, it is understood that the upper andlower limit, and each intervening value between the upper and lowerlimit of the range is encompassed within the embodiments.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity. The indefinite article “a” or “an” does not exclude aplurality. A single processor or other unit may fulfill the functions ofseveral items recited in the claims. The mere fact that certain measuresare recited in mutually different dependent claims does not indicatethat a combination of these measures cannot be used to advantage. Anyreference signs in the claims should not be construed as limiting thescope.

It will be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

All numbers expressing quantities of ingredients, reaction conditions,and so forth used in the specification are to be understood as beingmodified in all instances by the term ‘about.’ Accordingly, unlessindicated to the contrary, the numerical parameters set forth herein areapproximations that may vary depending upon the desired propertiessought to be obtained. At the very least, and not as an attempt to limitthe application of the doctrine of equivalents to the scope of anyclaims in any application claiming priority to the present application,each numerical parameter should be construed in light of the number ofsignificant digits and ordinary rounding approaches.

Furthermore, although the foregoing has been described in some detail byway of illustrations and examples for purposes of clarity andunderstanding, it is apparent to those skilled in the art that certainchanges and modifications may be practiced. Therefore, the descriptionand examples should not be construed as limiting the scope of thepresent disclosure to the specific embodiments and examples describedherein, but rather to also cover all modification and alternativescoming with the true scope and spirit of the present disclosure.

Exemplary Methods and Apparatus

Method 1. A computer-implemented method, comprising: receiving sensorinformation; calculating and storing estimated analyte measurementvalues based upon the received sensor information; determining one ormore communication conditions; instructing a transceiver to advertise toat least a first display device in accordance with one or morecommunication variables based upon the one or more communicationconditions; and transmitting the estimated analyte measurement values tothe at least first display device.

Method 2. The computer-implemented method of Method 1, wherein thesensor information is received from a continuous glucose monitoringsensor.

Method 3. The computer-implemented method of Method 1 or 2, wherein theanalyte measurement values comprise estimated glucose values.

Method 4. The computer-implemented method of Method 1 or 2, whereindetermining the one or more communication conditions comprisesdetermining at least one of the following: a time associated with thecommunication conditions; historical communication conditions; anexistence of an alarm condition; a condition of the continuous glucosemonitoring sensor; a condition of a user of the continuous glucosemonitoring sensor; and whitelist conditions.

Method 5. The computer-implemented method of Method 4, wherein the firstdisplay device is determined to be proximate to the continuous glucosemonitoring sensor based upon the time at which the estimated analytemeasurement values are to be transmitted.

Method 6. The computer-implemented method of Method 5, wherein the oneor more communication variables comprise at least one of an advertisingduration parameter and an advertising interval parameter according towhich advertising beacons are transmitted to the first display device,and wherein the at least one of the advertising duration and advertisinginterval parameters are adjusted to the first display device.

Method 7. The computer-implemented method of Method 4, wherein the firstdisplay device comprises one of a last-connected display devicepopulating the whitelist, a preferred display device populating thewhitelist, and a display device configured to advertise to at least asecond display device.

Method 8. The computer-implemented method of Method 4, wherein the alarmcondition comprises a determination that the condition of the user isapproaching or experiencing a medically critical state.

Method 9. The computer-implemented method of Method 8, wherein the oneor more communication variables are optimized for establishing awireless communication session with the first display device.

Method 10. The computer-implemented method of Method 9, wherein theoptimization of the one or more communication variables comprise atleast one of increasing a default advertising duration parameter anddecreasing a default advertising interval parameter.

Method 11. The computer-implemented method of Method 1 or 2, whereindetermining the one or more communication conditions comprises analyzingthe estimated analyte measurement values.

Method 12. The computer-implemented method of Method 11, wherein the oneor more communication variables are optimized for establishing awireless communication session with the first display device upon adetermination that the estimated analyte measurement values areindicative of a trend towards a medically critical state.

Method 13. The computer-implemented method of Method 11, wherein the oneor more communication variables are adjusted for delaying establishmentof a wireless communication session with the first display device upon adetermination that the estimated analyte measurement values areindicative of a trend towards a medically non-critical state.

Apparatus 14. An apparatus, comprising: signal conditioning circuitrycommunicatively connected to a continuous analyte sensor for receivingsensor information from the continuous analyte sensor indicative ofanalyte levels of a host to which the continuous analyte sensor isoperatively attached; a processor, wherein upon receiving the sensorinformation from the signal conditioning circuitry, instructs a radio toperform the following: transmit a plurality of advertising beacons to afirst display device in accordance with one or more communicationvariables based upon one or more communication conditions determined bythe apparatus; and upon the first display device responding to one ofthe plurality of advertising beacons, establish a wireless communicationsession with the first display device and transmit the sensorinformation or analyte values derived from the sensor information to theat least first display device.

Apparatus 15. The apparatus of Apparatus 14, wherein the sensorinformation comprises raw sensor data indicative of glucose levels ofthe host, and wherein the analyte values derived from the sensorinformation comprises estimated glucose values of the host.

Apparatus 16. The apparatus of Apparatus 14 or 15, wherein the one ormore communication variables comprise at least one of: a transmissionfrequency variable indicating a frequency with which the sensorinformation or the analyte values are transmitted to the first displaydevice; a transmission protocol indicating a wireless communicationprotocol to be utilized in the transmission of the sensor information orthe analyte values to the first display device; a communications typevariable indicating a one-way communication or a two-way communicationwith the first display during the transmission of the sensor informationor the analyte values to the first display device; and a transmissionoccurrence variable indicating whether the transmission of the sensorinformation or the analyte values to the first display device are tooccur in an on-demand or automatic manner.

Apparatus 17. The apparatus of Apparatus 14 or 15, wherein the one ormore communication variables comprise at least one of: a data packetformat type variable to be utilized for the transmission of theplurality of advertising beacons; an advertising duration variableindicative of a duration for which the first display device is to beadvertised to; an advertising interval variable indicative of an amountof time between the transmission of each of the plurality of advertisingbeacons; and a power variable indicative of power to be used by theradio for the transmission of the advertising beacons.

Apparatus 18. The apparatus of Apparatus 14 or 15, wherein the one ormore communication variables comprise at least one of: a display devicetype variable indicating a type of at least one of the first displaydevice and additional display devices to which the sensor information oranalyte values are to be sent; a display device number indicating anumber of display devices available to receive the sensor information oranalyte values; an order variable indicating a connection order ofdisplay devices previously having established a wireless communicationsession with the radio; a role variable indicating whether at least oneof the first display device and the additional display devices are atleast one of a primary display device, a secondary display device, apreferred display device, a scan-only display device, an advertisingdisplay device, and a sensor information or analyte values forwardingdisplay device; and a broadcast mode variable indicating one-way ortwo-way broadcasting to be used in conjunction with at least one of thefirst display device and the additional display devices if the at leastone of the first display device and the additional display devicescomprise an advertising display device or a sensor information oranalyte values forwarding display device.

Method 19. A computer-implemented method, comprising: calculating andstoring estimated glucose value data based upon glucose measurementsobtained by a continuous glucose monitoring sensor; determining one ormore communication conditions; and advertising to one or more displaydevices in a manner based on the one or more communication conditions.

Method 20. The computer-implemented method of Method 19, wherein thedetermination of the one or more communication conditions comprisesanalyzing historical estimated glucose value data.

Method 21. The computer-implemented method of Method 19 or 20, whereinthe analysis of the historical estimated glucose value data results inan observed trend.

Method 22. The computer-implemented method of Method 21, wherein thedetermination of the one or more communication conditions furthercomprises determining whether an alarm condition exists based on theobserved trend.

Method 23. The computer-implemented method of Method 22, wherein theadvertising to the one or more displays comprises incorporating theestimated glucose value data in advertising beacons upon a determinationthat no alarm condition exists.

Method 24. The computer-implemented method of Method 23, wherein theestimated glucose value data is incorporated in the advertising beaconsin an encrypted format.

Method 25. The computer-implemented method of Method 24, wherein theadvertising to the one or more displays comprises transmittingadvertising beacons to the one or more display devices upon adetermination that an alarm condition exists.

Method 26. The computer-implemented method of Method 25, wherein theadvertising beacons are transmitted in accordance with at least one ofan advertising duration and an advertising interval optimized for theone or more display devices.

Method 27. The computer-implemented method of Method 26, furthercomprising establishing wireless communication sessions during which theestimated glucose value data is transmitted to the one or more displaydevices upon the one or more display devices responding to theirrespective advertising beacons.

Method 28. The computer-implemented method of Method 27, furthercomprising encrypting the estimated glucose value prior to transmissionto the one or more display devices.

Apparatus 29. An apparatus, comprising: a continuous analyte sensoradapted to obtain raw analyte data; a processor and a memory unit havingcomputer code configured to cause the processor to: calculate and storeanalyte value data derived from the raw analyte data; determine one ormore communication conditions; and a radio adapted to advertise to oneor more display devices in a manner based on the one or morecommunication conditions.

Apparatus 30. The apparatus of Apparatus 29, wherein the computer codeconfigured to cause the processor to determine the one or morecommunication conditions comprises computer code configured to furthercause the processor to analyze historical analyte value data.

Apparatus 31. The apparatus of Apparatus 29 or 30, wherein the computercode configured to further cause the processor to analyze the historicalanalyte value data comprises computer code configured to further causethe processor to determine a trend.

Apparatus 32. The apparatus of Apparatus 31, wherein the computer codeconfigured to cause the processor to determine the one or morecommunication conditions comprises computer code configured to furthercause the processor to determine whether an alarm condition exists basedon the trend.

Apparatus 33. The apparatus of Apparatus 32, wherein the computer codeconfigured to cause the processor to advertise to the one or moredisplays comprises computer code configured to further cause theprocessor to incorporate the analyte value data in advertising beaconsupon a determination that no alarm condition exists.

Apparatus 34. The apparatus of Apparatus 33, wherein the analyte valuedata is incorporated in the advertising beacons in an encrypted format.

Apparatus 35. The apparatus of Apparatus 34, wherein the computer codeconfigured to cause the processor to advertise to the one or moredisplays comprises computer code configured to cause the processor totransmit advertising beacons to the one or more display devices upon adetermination that an alarm condition exists.

Apparatus 36. The apparatus of Apparatus 35, wherein the computer codeconfigured to further cause the processor to transmit advertisingbeacons comprises computer code configured to cause the processor totransmit the advertising beacons in accordance with at least one of anadvertising duration and an advertising interval optimized for the oneor more display devices.

Apparatus 37. The apparatus of Apparatus 36, wherein the radioestablishes wireless communication sessions with of the one or moredisplay devices during which the analyte value data is transmitted tothe one or more display devices upon the one or more display devicesresponding to their respective advertising beacons.

Apparatus 38. The apparatus of Apparatus 37, wherein the computer codeis configured to further cause the processor to encrypt the analytevalue data prior to transmission to the one or more display devices.

Apparatus 39. An apparatus, comprising: a memory; and a processor, thememory having computer code configured to cause the processor to:receive estimated glucose value data; and based upon observedcommunication conditions and communication variables adapted based onthe observed communication conditions, transmit the estimated glucosevalue data to one or more display devices.

Apparatus 40. The apparatus of Apparatus 39, wherein the apparatuscomprises a primary or preferred display device, and wherein theestimated glucose value data is received from a sensor electronicsmodule of a continuous glucose monitoring sensor system.

Apparatus 41. The apparatus of Apparatus 40, wherein the estimatedglucose value data is transmitted to a remote database for storage via anetwork and forwarded to the one or more display devices by a serveroperatively connected to the database via the network, wherein the oneor more display devices comprise secondary display devices.

Apparatus 42. The apparatus of Apparatus 40 or 41, wherein the apparatusand the one or more display devices are denoted as being the primary orpreferred display device and secondary display devices, respectively,within a whitelist maintained by the continuous glucose monitoringsensor system.

Apparatus 43. The apparatus of Apparatus 39, wherein the apparatuscomprises a first display device configured to act as an advertisingdisplay device, and wherein the apparatus transmits advertising beaconsto the one or more display devices on behalf of a continuous glucosemonitoring sensor system.

Apparatus 44. The apparatus of Apparatus 39, wherein the apparatuscomprises a first display device configured to act as a forward displaydevice, and wherein the apparatus transmits the estimated glucose valuedata to the one or more display devices on behalf of a continuousglucose monitoring sensor system.

Apparatus 45. The apparatus of Apparatus 39, further comprising a nearfield communications module adapted to cause a sensor electronics moduleof a continuous glucose monitoring sensor system from which theestimated glucose value data is received, to initiate advertisingprocesses for establishing a wireless communication session over whichthe estimated glucose value data is transmitted with at least one of theapparatus and the one or more display devices.

Any of the features of the exemplary methods and apparatus areapplicable to all aspects and embodiments identified herein, includingother exemplary methods and apparatus. Moreover, any of the features ofthe exemplary methods and apparatus are independently combinable, partlyor wholly with other aspects and embodiments identified herein or otherexemplary methods and apparatus described herein in any way, e.g., one,two, or three or more aspects, embodiments, exemplary methods and/orapparatus may be combinable in whole or in part. Further, any of thefeatures of the exemplary methods and apparatus may be made optional toother aspects or embodiments. Any aspect or embodiment of a method maybe performed by a system or apparatus of another aspect or embodiment,and any aspect or embodiment of a system or apparatus may be configuredto perform a method of another aspect or embodiment.

What is claimed is:
 1. A computer-implemented method, comprising:receiving sensor information; calculating and storing estimated analytemeasurement values based upon the received sensor information;determining one or more communication conditions; instructing atransceiver to advertise to at least a first display device inaccordance with one or more communication variables based upon the oneor more communication conditions; and transmitting the estimated analytemeasurement values to the at least first display device.
 2. Thecomputer-implemented method of claim 1, wherein the sensor informationis received from a continuous glucose monitoring sensor.
 3. Thecomputer-implemented method of claim 1, wherein the analyte measurementvalues comprise estimated glucose values.
 4. The computer-implementedmethod of claim 1, wherein determining the one or more communicationconditions comprises determining at least one of the following: a timeassociated with the communication conditions; historical communicationconditions; an existence of an alarm condition; a condition of thecontinuous glucose monitoring sensor; a condition of a user of thecontinuous glucose monitoring sensor; and whitelist conditions.
 5. Thecomputer-implemented method of claim 4, wherein the first display deviceis determined to be proximate to the continuous glucose monitoringsensor based upon the time at which the estimated analyte measurementvalues are to be transmitted.
 6. The computer-implemented method ofclaim 5, wherein the one or more communication variables comprise atleast one of an advertising duration parameter and an advertisinginterval parameter according to which advertising beacons aretransmitted to the first display device, and wherein the at least one ofthe advertising duration and advertising interval parameters areadjusted to the first display device.
 7. The computer-implemented methodof claim 4, wherein the first display device comprises one of alast-connected display device populating the whitelist, a preferreddisplay device populating the whitelist, and a display device configuredto advertise to at least a second display device.
 8. Thecomputer-implemented method of claim 4, wherein the alarm conditioncomprises a determination that the condition of the user is approachingor experiencing a medically critical state.
 9. The computer-implementedmethod of claim 8, wherein the one or more communication variables areoptimized for establishing a wireless communication session with thefirst display device.
 10. The computer-implemented method of claim 9,wherein the optimization of the one or more communication variablescomprise at least one of increasing a default advertising durationparameter and decreasing a default advertising interval parameter. 11.The computer-implemented method of claim 1, wherein determining the oneor more communication conditions comprises analyzing the estimatedanalyte measurement values.
 12. The computer-implemented method of claim11, wherein the one or more communication variables are optimized forestablishing a wireless communication session with the first displaydevice upon a determination that the estimated analyte measurementvalues are indicative of a trend towards a medically critical state. 13.The computer-implemented method of claim 11, wherein the one or morecommunication variables are adjusted for delaying establishment of awireless communication session with the first display device upon adetermination that the estimated analyte measurement values areindicative of a trend towards a medically non-critical state.
 14. Anapparatus, comprising: signal conditioning circuitry communicativelyconnected to a continuous analyte sensor for receiving sensorinformation from the continuous analyte sensor indicative of analytelevels of a host to which the continuous analyte sensor is operativelyattached; a processor, wherein upon receiving the sensor informationfrom the signal conditioning circuitry, instructs a radio to perform thefollowing: transmit a plurality of advertising beacons to a firstdisplay device in accordance with one or more communication variablesbased upon one or more communication conditions determined by theapparatus; and upon the first display device responding to one of theplurality of advertising beacons, establish a wireless communicationsession with the first display device and transmit the sensorinformation or analyte values derived from the sensor information to theat least first display device.
 15. The apparatus of claim 14, whereinthe sensor information comprises raw sensor data indicative of glucoselevels of the host, and wherein the analyte values derived from thesensor information comprises estimated glucose values of the host. 16.The apparatus of claim 15, wherein the one or more communicationvariables comprise at least one of: a transmission frequency variableindicating a frequency with which the sensor information or the analytevalues are transmitted to the first display device; a transmissionprotocol indicating a wireless communication protocol to be utilized inthe transmission of the sensor information or the analyte values to thefirst display device; a communications type variable indicating aone-way communication or a two-way communication with the first displayduring the transmission of the sensor information or the analyte valuesto the first display device; and a transmission occurrence variableindicating whether the transmission of the sensor information or theanalyte values to the first display device are to occur in an on-demandor automatic manner.
 17. The apparatus of claim 15, wherein the one ormore communication variables comprise at least one of: a data packetformat type variable to be utilized for the transmission of theplurality of advertising beacons; an advertising duration variableindicative of a duration for which the first display device is to beadvertised to; an advertising interval variable indicative of an amountof time between the transmission of each of the plurality of advertisingbeacons; and a power variable indicative of power to be used by theradio for the transmission of the advertising beacons.
 18. The apparatusof claim 15, wherein the one or more communication variables comprise atleast one of: a display device type variable indicating a type of atleast one of the first display device and additional display devices towhich the sensor information or analyte values are to be sent; a displaydevice number indicating a number of display devices available toreceive the sensor information or analyte values; an order variableindicating a connection order of display devices previously havingestablished a wireless communication session with the radio; a rolevariable indicating whether at least one of the first display device andthe additional display devices are at least one of a primary displaydevice, a secondary display device, a preferred display device, ascan-only display device, an advertising display device, and a sensorinformation or analyte values forwarding display device; and a broadcastmode variable indicating one-way or two-way broadcasting to be used inconjunction with at least one of the first display device and theadditional display devices if the at least one of the first displaydevice and the additional display devices comprise an advertisingdisplay device or a sensor information or analyte values forwardingdisplay device.
 19. A computer-implemented method, comprising:calculating and storing estimated glucose value data based upon glucosemeasurements obtained by a continuous glucose monitoring sensor;determining one or more communication conditions; and advertising to oneor more display devices in a manner based on the one or morecommunication conditions.
 20. The computer-implemented method of claim19, wherein the determination of the one or more communicationconditions comprises analyzing historical estimated glucose value data.21. The computer-implemented method of claim 19, wherein the analysis ofthe historical estimated glucose value data results in an observedtrend.
 22. The computer-implemented method of claim 21, wherein thedetermination of the one or more communication conditions furthercomprises determining whether an alarm condition exists based on theobserved trend.
 23. The computer-implemented method of claim 22, whereinthe advertising to the one or more displays comprises incorporating theestimated glucose value data in advertising beacons upon a determinationthat no alarm condition exists.
 24. The computer-implemented method ofclaim 23, wherein the estimated glucose value data is incorporated inthe advertising beacons in an encrypted format.
 25. Thecomputer-implemented method of claim 24, wherein the advertising to theone or more displays comprises transmitting advertising beacons to theone or more display devices upon a determination that an alarm conditionexists.
 26. The computer-implemented method of claim 25, wherein theadvertising beacons are transmitted in accordance with at least one ofan advertising duration and an advertising interval optimized for theone or more display devices.
 27. The computer-implemented method ofclaim 26, further comprising establishing wireless communicationsessions during which the estimated glucose value data is transmitted tothe one or more display devices upon the one or more display devicesresponding to their respective advertising beacons.
 28. Thecomputer-implemented method of claim 27, further comprising encryptingthe estimated glucose value prior to transmission to the one or moredisplay devices.